Safety and Feasibility Between Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer：A Prospective Cohort Study
Conditions: Gastric Cancer
Sponsor: Southwest Hospital, China

Study protocol 
 
 
Safety and feasibility between Robotic and laparoscopic D2 
radical total gastrectomy for locally advanced gastric cancer： 
A prospective cohort study（NCT03500471） 
Study protocol 
 
 
 
Research center: Southwest Hospital, China 
 
 
 
 
Principle Investigator: 
 
Prof. Peiwu Yu, M.D. 
 
Department of General Surgery and Center of Microinvasive 
Gastrointestinal Surgery,Southwest Hospital, China, Address: Gaotanyan 
Main Street 29, Shapingba District, Chongqing 400038, China 
Telephone: +86-023-68754161, Fax: +86-023-68754161 
 
E-mail:yupeiwu01@sina.com 
No. of edition: V2.0 
Date of edition: 2018.01.08 

Study protocol 
I 
 
 
Summary 
 
Scenario Title 
Safety and feasibility between Robotic and laparoscopic D2 
radical total gastrectomy for locally advanced gastric cancer: A 
prospective cohort study（NCT03500471） 
Scenario Version V2.0 
Sponsor 
Peiwu Yu 
Research 
Center 
Department of General Surgery and Center of Microinvasive 
Gastrointestinal Surgery, Southwest Hospital, China 
Indications 
Patients diagnosed with gastric cancer who need to received total 
gastrectomy with D2 lymphadenectomy. (cT2-4a, N0/+, M0) 
Purpose of 
research 
To investigate the safety and feasibility between Robotic and 
laparoscopic radical total gastrectomy with D2 lymphadenectomy for 
locally advanced gastric cancer. 
Research 
design 
prospective, single-center, non-randomized, controlled, non-blind, and 
non-inferiority observation trial 
 
Case grouping 
Group A (Experimental): Robotic-assisted Total Gastrectomy with D2 
Lymphadenectomy 
Group B(Compared): Laparoscopic-assisted Total Gastrectomy with D2 
Lymphadenectomy 
 
The basis for 
determining 
the sample size 
This study is a non-inferiority study, with postoperative complications as 
primary outcome. According to the relevant studies, the postoperative 
complication rate of laparoscopic total gastric surgery is about 15%.In 
this study, it was assumed that the postoperative complication rate of the 
study group was similar to the control group, with α=0.05, β=0.2, and the 
non-inferiority threshold value set as 15%. PASS 11 was used for 
calculation, and the sample size of each group was 68 cases. Considering 
that the maximum detachment rate of this clinical study was 10%, the 
final sample size was 75 cases in each group. 
Inclusion 
criteria 
⚫ Age between 18 and 80 years 
⚫ Endoscopic biopsy and CT confirmed locally advanced gastric 
adenocarcinoma, requiring D2 radical gastrectomy. 
⚫ Preoperative examination showed no absolute contraindication and 
no distant metastasis  
⚫ Performance status of 0 or 1 on ECOG scale 
⚫ ASA class I, II, or III 
⚫ Written informed consent 

Study protocol 
II 
 
 
 
Exclusion 
criteria 
⚫ Enlarged or bulky regional lymph node (diameter over 3cm) 
supported by preoperative imaging including those surrounding 
important vessels  
⚫ Emergency surgery due to complication (bleeding, obstruction or 
perforation) caused by gastric cancer  
⚫ Previous 
upper 
abdominal 
surgery 
(except 
laparoscopic 
cholecystectomy) 
⚫ Previous neoadjuvant chemotherapy or radiotherapy 
⚫ Unstable myocardial infarction, angina, or cerebrovascular 
accident within the past 6 months 
⚫ FEV1＜50% of predicted values 
⚫ Other malignant diseases 
⚫ Severe mental disorder 
⚫ Women during breast-feeding or pregnancy 
Withdraw 
criteria 
⚫ Patients intraoperatively/postoperatively confirmed as T4b 
⚫ M1 tumor confirmed intraoperatively or postoperatively: distant 
metastasis 
only 
found 
by 
intraoperative 
exploration 
or 
postoperative pathological biopsy or a positive postoperative 
peritoneal lavage cytology examination 
⚫ Requirement of simultaneous surgery for other diseas 
⚫ Patients intraoperatively confirmed as unable to complete D2 
lymph node dissection/R0 resection due to tumor: unable to 
complete R0 resection due to regional lymph node integration into 
a mass or surrounded with important blood vessels, which cannot 
be resected 
⚫ Sudden severe complications during the perioperative period 
(intolerable surgery or anesthesia), which renders it unsuitable or 
unfeasible to implement the study treatment protocol as scheduled 
⚫ Patients who voluntarily quit or discontinue treatment for personal 
reasons at any stage after inclusion in this study 
⚫ Treatment implemented is proven to violate study protocol 

Study protocol 
IV 
 
 
 
` 
Outcome 
Measures 
Primary Outcome Measures： 
⚫ Overall postoperative morbidity rates 
Secondary Outcome Measures： 
⚫ Intraoperative morbidity rate 
⚫ Operative time 
⚫ Estimated blood loss 
⚫ Number of harvested and metastatic lymph nodes 
⚫ the lengths of incision, proximal and distal margins 
⚫ Time to first flatus 
⚫ Time to first liquid diet 
⚫ Postoperative hospital stay 
⚫ Total cost 
Statistical 
considerations 
All data analyses will be performed using SPSS statistical software, 
version 23.0 (SPSS Inc), and the R software environment (R 
Foundation for Statistical Computing). 
All data analyses will be conducted on a per-protocol (PP) basis. This 
study does not fill in missing values. Normally distributed continuous 
variables will be presented as mean and standard deviation and 
compared using  the t-test if normally distributed, or as median and 
interquartile range and compared using the Wilcoxon rank-sum test if 
non-normally distributed; while categorical data will be presented as 
number and percentages and compared using the Pearson χ2 test or the 
Fisher exact test, as appropriate. Sensitivity analysis is used for extreme 
outlier data. The confidence interval of the parameters is estimated with 
a 95% confidence interval. The central effect analysis and subgroup 
analysis are conducted according to the specific situation. All the 
statistical tests were tested by two sides. A p-value <0.05 is considered 
statistically significant. 

Study protocol 
V 
 
 
1. Research background 
Gastric cancer is a common malignant tumor, and its incidence and mortality are 
second only to lung cancer. According to estimates by National Cancer Registry of 
China, there were about 4.29 million new cancer patients and 2.81 million cancer deaths 
in China in 2015, of which 679,000 new gastric cancer patients and 498,000 gastric 
cancer deaths were reported[1]. About 90% of patients in China have advanced gastric 
cancer at the time of diagnosis. According to statistics, 65% of patients with advanced 
gastric cancer who have a T stage reaching T3 or T4, and as many as 85% of patients 
with lymph node metastases occur. Without surgical intervention, the median survival 
time for advanced gastric cancer is only 5.4 months[2]. Although many advances have 
been made in treatment, radical surgery is still the main treatment method for the gastric. 
In recent years, with changes in dietary habits and other factors, the incidence of 
proximal gastric cancer and esophagogastric junction carcinoma has gradually 
increased[3, 4]. According to UICC, AJCC, JGCA and the consensus and treatment 
guidelines of Chinese experts, total gastrectomy with D2 lymphadenectomy has become 
the standard operation for upper gastric cancer and esophagogastric junction 
carcinoma[5]. 
Since Kitano first reported the feasibility and safety of laparoscopic radical gastrectomy, 
laparoscopic radical gastrectomy has been widely carried out. At present, the multi-
center prospective randomized controlled study with large-sample has confirmed that 
early gastric cancer of laparoscopic radical gastrectomy is safe and feasible. It can 
achieve the effect of radical tumor resection. The long-term follow-up results show that 
its clinical efficacy is comparable to that of traditional open surgery, and it has 
significant minimally invasive advantages. Laparoscopic radical gastrectomy for early 
gastric cancer has become a recommended treatment guideline[5].A multi-center 
prospective study on distal subtotal gastrectomy for advanced gastric cancer shows that 
laparoscopic D2 radical distal gastrectomy is safe and feasible[6, 7]. The current research 
on laparoscopic D2 radical total gastrectomy shows that laparoscopic D2 radical total 
gastrectomy is safe and feasible, and the long-term effect is comparable to that of 
laparotomy. Haverkamp et al. [8] meta-analysis that included 314 cases of laparoscopy 

Study protocol 
VI 
 
 
and 384 cases of open total gastrectomy showed that although laparoscopy had longer 
operation time, it could significantly reduce intraoperative blood loss and postoperative 
complication rate and significantly shorten the length of hospital stay. Etoh et al.[9] 
conducted a propensity matching analysis of 2494 cases of laparoscopic and open total 
gastrectomy patients who were registered online in Japan during 2014-2015, and found 
that there was no statistical difference in surgical complications, including anastomotic 
fistula and pancreatic fistula, and there was no difference in early postoperative 
mortality, reoperation rate and readmission rate between the two groups. However, the 
laparoscopic group had significantly less intraoperative bleeding, more lymph node 
dissection, and shorter postoperative hospital stay.Hu Jiankun et al. [10] retrospectively 
analyzed 69 patients and 268 patients who underwent laparoscopic and open D2 radical 
total gastrectomy from 2006 to 2015, respectively. There were no significant differences 
between the two groups in terms of total lymph node dissection, blood loss, 
postoperative hospitalization days, and early postoperative complications, and there 
were no significant differences in 3-year and 5-year postoperative survival rates 
between the two groups. We analyzed retrospectively 234 patients with D2 radical total 
gastrectomy during 2004-2010 with PSM, the number of the lymph node and length of 
margins in the two groups of patients and there were no significant differences, in terms 
of  intraoperative blood loss, postoperative hospitalization days and postoperative pain, 
laparoscopic group were significantly better than the open group, The incidence of early 
postoperative complications was also lower than that of open surgery, and the overall 
five-year survival rate of the two groups was similar[11]. 
However, traditional laparoscopic surgery has some limitations, such as limited 
mobility of laparoscopic instruments, limited field of view, and the two-dimensional 
plane, lack of three-dimensionality. Due to the complex anatomical structure of the 
surrounding gastric vessels and the close proximity of blood vessels, it is easy to cause 
intraoperative bleeding during the lymph node dissection. Moreover, the operation time 
is long and the learning curve is also long. Especially for patients with obesity, large 
anteroposterior diameter, and small rib arch angle, the difficulty will be greater, because 
the deep and narrow abdominal space will seriously affect the laparoscopic surgery. 

Study protocol 
VII
 
 
In 2000, robotic-assisted surgery began to be used in clinical practice. Due to the 3D 
high-definition images, the elimination of tremor and the flexibility of operation,  
robotic-assisted surgery has gradually become a frontier and research hotspot in the 
field of minimally invasive surgery[12].In 2003, In 2003, Hashizume was the first to 
report the robotic-assisted radical gastrectomy. Since then, many studies and meta-
analyses have confirmed that robot-assisted radical gastrectomy can achieve the same 
short-term and long-term clinical efficacy as laparoscopy[13-15]. However, at present, 
most studies on robotic-assisted gastric surgery are on distal gastric cancer, and there 
are few reports comparing robotic and laparoscopic total gastrectomy. Yoon et al. [16] 
retrospectively analyzed 36 patients and 65 patients who underwent robotic and 
laparoscopic total gastrectomy from 2009 to 2011. There are no significant differences 
between the two groups in terms of intraoperative blood loss, postoperative 
hospitalization days, postoperative complications, and the total number of lymph node 
dissection. However, the study has a certain limition. These lymph node dissection 
method are not completely D2 radical resection. Meanwhile，the proportion of patients 
with early gastric cancer reached 70%. Son et al. [17] retrospectively analyzed 51 
patients and 58 patients who underwent total gastrectomy with robotic and laparoscopic 
splene-preserving D2 during 2003-2010. The operative time of robotic-assisted surgery 
group was longer than that of the laparoscopic group, and there were no significant 
differences between the two groups in intraoperative blood loss, postoperative hospital 
stay, postoperative first flatus and intake time, postoperative complications, and the 
total number of lymph node dissection, but more lymph node dissection was performed 
by the robot at 10 and 11p than by the laparoscope (3.6vs1.9;P =0.014). Meanwhile，
there was no significant difference in the 5-year overall survival rate and disease-free 
survival rate between the two groups, but 70% of the cases were early gastric cancer. 
The above-mentioned literatures suggests that robotic versus laparoscopic total 
gastrectomy is safe and feasible, but the number of reported cases is small, and most of 
them are patients with early gastric cancer. In China, 90% of patients are diagnosed with 
advanced gastric cancer, and total gastrectomy for advanced gastric cancer is more 
difficult and has a wider range of lymph node dissection. Therefore, it is more necessary 

Study protocol 
VII
 
 
to conduct clinical research on robotic-assisted radical gastrectomy with D2 
lymphadenectomy for locally advanced gastric cancer. At present, there is no 
prospective study report on the treatment of locally advanced gastric cancer with robot 
and laparoscopic D2 lymph node dissection. 
Our center reported the first robotic-assisted gastrectomy in China in 2010, and has 
completed more than 600 cases of robotic-assisted gastrectomy. At present, there is a 
lack of prospective research literature reports on robot and  laparoscopic radical total 
gastrectomy combined with D2  lymphadenectomy in the treatment of locally advanced 
gastric cancer, and the safety and effectiveness of robotic and laparoscopic radical total 
gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer are still 
unclear. This study intends to conduct the first international prospective study of robot 
and laparoscopic radical total gastrectomy with D2 lymphadenectomy for the treatment 
of locally advanced gastric cancer, and to provide evidence-based medicine for the 
widespread development of robot-assisted total gastrectomy for locally advanced gastric 
cancer. 
2. Objective 
The purpose of the prospective trial is to investigate the safety and feasibility 
between Robotic and laparoscopic radical total gastrectomy with D2 lymphadenectomy 
for locally advanced gastric cancer. 
3. Research design 
prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority 
observation trial 
3.1 Single center 
 
Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, 
Southwest Hospital, China 
3.2 Case group 
Group A (Experimental): Robotic-assisted Total Gastrectomy with D2 Lymphadenectomy 
Group B(Compared): Laparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy 
3.3 Estimate sample size 
This study is a non-inferiority study, with postoperative complications as primary 
outcome. According to the relevant studies, the postoperative complication rate of 
laparoscopic total gastric surgery is about 15%.In this study, it was assumed that the 

Study protocol 
IX 
 
 
postoperative complication rate of the study group was similar to the control group, with 
α=0.05, β=0.2, and the non-inferiority threshold value set as 15%. PASS 11 was used for 
calculation, and the sample size of each group was 68 cases. Considering that the 
maximum detachment rate of this clinical study was 10%, the final sample size was 75 
cases in each group. 
3.4 Blind method：This research adopts an open design 
3.5 Research cycle 
Estimated enrollment cycle: complete enrollment within 3 years 
Follow-up period: begin at the enrollment of the first case and end 1 month after 
the enrollment of the last case. 
Estimated time: 2018.01.08-2021.01.08(to complete enrollment)- 2021.02.08(to 
complete follow-up) 
4. Study objects 
All patients who meet the inclusion criteria and not conform to the exclusion 
criteria are qualified for this study. 
4.1 Inclusion criteria 
(1) Age between 18 and 80 years 
(2) Endoscopic biopsy and CT confirmed locally advanced gastric adenocarcinoma, requiring D2 
radical gastrectomy. 
(3) Preoperative examination showed no absolute contraindication and no distant metastasis 
(4) Performance status of 0 or 1 on ECOG scale 
(5) ASA class I, II, or III 
(6) Written informed consent 
4.2 Exclusion criteria 
(7) Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative 
imaging including those surrounding important vessels  
(8) Emergency surgery due to complication (bleeding, obstruction or perforation) caused by 
gastric cancer  
(9) Previous upper abdominal 
surgery(except laparoscopic cholecystectomy) 
(10) Previous neoadjuvant chemotherapy or radiotherapy 
(11) Unstable 
myocardial 
infarction, 
angina, or 
cerebrovascular accident within 
the past 6 months 
(12) FEV1＜50% of predicted values 
(13) Other malignant diseases 

Study protocol 
X 
 
 
(14) Severe mental disorder 
(15) Women during breast-feeding or pregnancy 
4.3 Withdraw criteria 
(16) Patients intraoperatively/postoperatively confirmed as T4b 
(17) M1 tumor confirmed intraoperatively or postoperatively: distant metastasis only found by 
intraoperative exploration or postoperative pathological biopsy or a positive postoperative 
peritoneal lavage cytology examination 
(18) Requirement of simultaneous surgery for other diseas 
(19) Patients intraoperatively confirmed as unable to complete D2 lymph node dissection/R0 
resection due to tumor: unable to complete R0 resection due to regional lymph node 
integration into a mass or surrounded with important blood vessels, which cannot be resected 
(20) Sudden severe complications during the perioperative period (intolerable surgery or 
anesthesia), which renders it unsuitable or unfeasible to implement the study treatment 
protocol as scheduled 
(21) Patients who voluntarily quit or discontinue treatment for personal reasons at any stage after 
inclusion in this study 
(22) Treatment implemented is proven to violate study protocol. 
5. Outcome Measures 
5.1 Primary Outcome Measures 
⚫ Overall postoperative morbidity rates 
5.2 Secondary Outcome Measures 
⚫ Intraoperative morbidity rate 
⚫ Operative time 
⚫ Estimated blood loss 
⚫ Number of harvested and metastatic lymph nodes 
⚫ the lengths of incision, proximal and distal margins 
⚫ Time to first flatus 
⚫ Time to first liquid diet 
⚫ Postoperative hospital stay 
⚫ Total cost 
6. Diagnostic criteria for this study 
(1) The AJCC-8th TNM tumor staging system will be used for this study. 
(2) Diagnostic criteria and classification of gastric cancer: According to the 
histopathological international diagnostic criteria, classification will be divided into 

Study protocol 
XI 
 
 
papillary 
adenocarcinoma 
(pap), 
tubular 
adenocarcinoma 
(tub), 
mucinous 
adenocarcinoma (muc), signet ring cell carcinoma (sig), and poorly differentiated 
adenocarcinoma (por). 
(3) Definition of advanced stage: tumor infiltration of the stomach wall reaches or 
exceeds the inherent muscular layer (T2); T2, T3, and T4a patients will be included as 
study subjects, whereas T4b patients will not. 
(4) Definition of esophagogastric junction carcinoma: According to the AJCC-8th 
tumor staging system, esophagogastric junction carcinoma is defined as a tumor whose 
tumor center is located within 5cm above and below the esophagogastric junction. 
According to Siewert classification, the tumor was divided into Siewert type I : the 
tumor center was located 1 ~ 5 cm above the esophagogastric boundary; Siewert type II : 
The center of the tumor was 1 cm to 2 cm above the esophagogastric boundary.Siewert 
type III : The tumor center is located 2 to 5 cm below the esophagogastric boundary. 
Only Siewert type III esophagogastric junction carcinoma were involved in this study. 
7 Qualifications of the participated Surgeons 
7.1 Basic principle 
All candidate surgeons in this study met the following criteria: 
(1) Performed at least 30 robotic radical total gastrectomies. 
(2) Performed at least 50 laparoscopic radical total gastrectomies. 
 
8. End point and definition of related result determination 
8.1 Incidence of operative complications 
The number of all patients treated with surgery as the denominator and the number 
of the patients with any intraoperative and postoperative complications as the  numerator 
are used to calculate the proportions. The criteria for the intraoperative complications 
refer to the descriptions of intraoperative complications in the observation project (in 
9.3.3). 

Study protocol 
XII
 
 
8.1.1 Incidence of intraoperative complications 
With the number of patients undergoing surgery as the denominator, the number of 
patients with any of the following intraoperative complications is calculated as 
numerator. Intraoperative complications are based on the intraoperative complications 
mentioned in the intraoperative observations. 
8.1.2 Incidence of postoperative complications 
The number of all patients treated with surgery as the denominator and the number 
of the patients with any intraoperative and postoperative complications as the  
numerator are used to calculate the proportions. 
8.1.3 Incidence of overall postoperative complications: The postoperative 
complication criteria refer to short-term complications after surgery in the postoperative 
observation project. The time is defined as within 30th after surgery, or the first 
discharge time if the days of hospital stay more than 30 days. 
8.1.4 Incidence of postoperative major complications: The standard for 
postoperative major complications refers to the short-term complications in the 
postoperative observation project. according to the Clavien–dindo grade, IIIA level and 
above for serious complications, and when multiple complications occur simultaneously, 
the highest ranked complication is the subject. 
8.2 Mortality 
• 
The number of all the patients receiving surgery as the denominator and the 
number of the patients in any of the following situations as the numerator are used to 
calculate proportions. This proportion indicated the operative mortality ratio. 
• 
Situations: patients whose death was identified according to documented 
intraoperative observation items, including patients who die within 30 days after the 
surgery (including 30 days) regardless of the causality between the death and the 
surgery, and patients who die more than 30 days after the surgery (whose death is 
proved to have a direct causal relationship with the first operation). 
8.3 Determination of surgical outcomes 
8.3.1 Operative time: from skin incision to the skin being sutured 
8.3.2 Postoperative recovery indexes 
8.3.2.1 Time to ambulation, flatus, recovery of liquid diet and semi-liquid diet. 
• During the day of surgery to the first discharge, the initial time to ambulation, flatus, 
liquid diet and semi-liquid diet during the postoperative hospitalization is recorded by 

Study protocol 
XII
 
 
hour. 
• Flatus on the operation day should be excluded. 
• If flatus or resumption of liquid and semi-liquid diet does not occur before hospital 
discharge, the discharge time should be recorded as the corresponding time. 
• 
The initial time to ambulation, flatus, liquid diet and semi-liquid diet should be 
recorded according to patients’ reports. 
8.3.2.2 Lymph node metastasis 
• The number of lymph nodes in each group was used as the denominator, the number 
of lymph nodes in the final pathological report was used as the molecule, and the 
proportion of lymph node metastasis in each group was obtained. The proportion of total 
gastric lymph node metastasis was calculated 
9 Standard operating procedures (SOP) 
9.1 Case selection 
9.1.1 Selection assessment items 
Clinical examination data of patients conducted from hospital admission to 
enrollment into 
this study (time period is usually 2 weeks) will be considered baseline data, and must 
include: 
(1) Systemic status: ECOG score, height, weight, BMI, ASA score; 
(2) Peripheral venous blood: Hb、RBC、WBC、LYM、NEU、NEU%、PLT、
MONO 
(3) Blood biochemistry: albumin, prealbumin, total bilirubin, indirect bilirubin, direct 
bilirubin, AST, ALT, creatinine, urea nitrogen, Total cholesterol, triglycerides, 
fasting glucose, potassium, sodium, chlorine, calcium 
(4) Serum tumor markers: CEA、CA19-9、CA72-4、CA12-5、AFP 
(5) Full abdominal (slice thickness of 10mm or less, in case of allergy to the contrast 
agent, CT horizontal scanning is allowed only) 
(6) Upper gastrointestinal endoscopic ultrasonography (EUS) and biopsy, if no EUS, 
select ordinary upper gastrointestinal endoscopy and biopsy instead 
(7) Chest X-ray (AP and lateral views): cardiopulmonary conditions(Chest CT 
replacement is permitted) 
(8) Resting 12-lead ECG 

Study protocol 
XIV
 
 
(9) Respiratory function tests: FEV1, FVC 
9.1.2 Selection application 
For cases that meet all inclusion criteria and none of the exclusion criteria, talk to 
patients and their families and sign informed consent. Application and confirmation of 
eligibility should be completed preoperatively; postoperative applications will not be 
accepted. 
9.2 Preoperative management 
⚫ In case of any deterioration of the clinical conditions from the selection time to the 
expected day of surgery, whether to undergo an elective surgery as planned should be 
decided in accordance with the judgment of the doctor in charge; if an emergency 
surgery is required, the case should be withdrawn from PP set according to  Withdrawal 
Criteria; 
⚫ For patients with nutritional risks, preoperative enteral/parenteral nutritional 
support is allowed. 
⚫ For elderly, smokers, high-risk patients with diabetes, obesity, and chronic 
cardiovascular/cerebrovascular 
or 
thromboembolic 
history, 
among 
others, 
perioperative 
low-molecular-weight 
heparin 
prophylaxis, 
 
lower-limb 
antithrombotic massage, active lower limb massage, training in respiratory function, 
and other preventive measures are recommended. For other potentially high-risk 
complications not specified in this study protocol, the doctor in charge can decide 
on the most appropriate approach according to clinical practice and should record it 
in the CRF. 
⚫ For the operative approach of the surgeries in this study should be selected by the 
doctor in charge according to his/her experience and the specific intraoperative 
circumstances. 
⚫ Preoperative fasting and water deprivation and other before-anesthesia 
requirements on patients should follow the conventional anesthesia program, which 
is not specified in this study. 
⚫ For prophylactic antibiotics, the first intravenous infusion should begin 30 minutes 
before surgery. It is recommended to select a second-generation cephalosporin 
(there are no provisions on specific brands in this study); the preparation, 
concentration, and infusion rate should comply with routine practice; and 
prophylaxis should not exceed postoperative 24 hours (special case can be extended 
to 48 hours) at a frequency of one infusion every 12 hours. If a patient is allergic to 

Study protocol 
XV
 
 
cephalosporins (including the history of allergy or allergy after cephalosporin 
administration), other types of antibiotics are allowed according to the specific 
clinical situation and when used over the same period mentioned. 
9.3 Standardization of surgical practice 
9.3.1 Principle of Surgical Treatments 
9.3.1.1 Anesthesia 
The operation is to be carried out with endotracheal intubation under general 
anesthesia; whether epidural assisted anesthesia is applied or not is left at the discretion 
of the anesthetist and is not specified in this study protocol. 
9.3.1.2 Regulations on punctures and auxiliary incision 
The positions of punctures and auxiliary small incision are not specified; the 
number of punctures should not exceed 5. There should be only one auxiliary small 
incision whose length shall not exceed the maximum tumor diameter and necessarily 
will be less than 10 cm in normal cases. If the auxiliary small incision needs to be 
longer than 10 cm, the surgeon in charge should make a decision and record the reasons 
in the CRF. 
9.3.1.3 Intraoperative exploration 
Explore the abdominal cavity for any hepatic, peritoneal, mesenteric, or pelvic 
metastases and gastric serosal invasion 
9.3.1.4 Regulations on the extent of the gastrectomy 
Follow the Japanese gastric cancer treatment guidelines 2014 (ver. 4) to perform 
total gastrectomy under the premise of satisfying the oncological principles. 
9.3.1.5 Regulations on the extent of the Lymph node dissection 
Follow the Japanese gastric cancer treatment guidelines 2014 (ver. 4): Total gastric 
resection with D2 Lymphadenectomy (No. 1,2,3,4,5,6,7,8a,9,10,11,12a). 
9.3.1.6 Regulations Regarding Greater Omentum Resection 
This study protocol requires total greater omentum resection. 
9.3.1.7 Regulations Regarding Digestive Tract Reconstruction 
The digestive tract reconstruction method is determined by the surgeon according 
to his/her own experience and the specific intraoperative situation. If instrumental 
anastomosis is used, the surgeon determines whether manual reinforced stitching of the 
anastomotic stoma is to be performed; the study protocol does not specify. 

Study protocol 
XV
 
 
9.3.1.8 Regulations Regarding Surgery-related Equipment and Instruments 
The energy equipment, vascular ligation method, digestive tract cutting closure, 
and digestive tract reconstruction instruments are determined by the  surgeon 
responsible for surgery based on experience and actual needs and are not specified in 
this study protocol. 
9.3.1.9 Regulations Regarding Gastric Canal and Peritoneal Drainage Tube 
Whether the gastric canal or peritoneal drainage tube is left after surgery is 
determined by experience and actual needs and is not specified in this study 
protocol,and record the reasons in the CRF. 
9.3.1.10 
Regulations Regarding Concurrent Surgical Treatments 
If another organ/system disease is present, the responsible surgeon and the relevant 
department consultants will jointly decide whether a concurrent operation is required 
and can be performed. The order is determined according to the clinical routine, but 
these cases will be excluded from the PP set according to the Exclusion Criteria. 
9.3.1.11 Regulations Regarding the Processing of Excluded Patients Identified 
Intraoperatively 
If the patient is judged to meet the exclusion requirements during the operation,  
the study approach will be suspended, and the responsible surgeon will decide upon the 
subsequent treatment according to the clinical practice of the research center (the 
therapeutic decision, such as whether to excise the gastric primary focus or metastases, 
is determined by the responsible surgeon). These cases will be excluded from the PP set 
according to the Exclusion Criteria. 
9.3.1.12 Regulations on conversion to laparotomy 
When intra-abdominal hemorrhage, organ damage and other serious/life-
threatening complications which are difficult to control occur during  robotic surgery, it 
is necessary to actively convert to laparotomy. If the anesthesiologist and surgeon 
consider that intraoperative complications caused by carbon dioxide pneumoperitoneum 
may threaten the patient’s life, it is necessary to actively convert to open. The surgeon 
in charge can decide to convert to laparotomy driven by other technical or equipment 
reasons and will record said reasons. The reasons for the conversion to open must be 
clearly recorded in the CRF. The incision length of > 10 cm is defined as a case of 

Study protocol 
XV
 
 
conversion to open surgery in this study. 
9.3.2 Operative parameters (same for both groups) 
Completed by the research assistant on the day of the operation. specific projects 
include: 
(1) Name of responsible surgeons 
(2) Operation time (min) 
(3) Type of operation, digestive tract reconstruction, intraoperative damage and whether 
the tumor was ruptured during surgery (intact rupture of the capsule) 
(4) Length of incision (cm) 
(5) Conversion to open surgery or not and the reasons for this decision 
(6) Intraoperative estimated blood loss (ml; from skin cutting to stitching, intraoperative 
blood loss = (postoperative gauze weight, grams - preoperative gauze weight, 
grams) *1ml/g+ suction fluid, ml) 
(7) Blood transfusion (ml): 
in this study, the blood transfusion event is defined as 
transfusion of red cell suspension (ml) or whole blood (ml) 
(8) Tumor location 
 
(9) Tumor size (maximum tumor diameter, mm) 
(10) Number of lymph nodes dissected in each group and distant metastasis (location) 
(11) 
Proximal 
resected 
margin 
(mm), 
distal 
resected 
margin 
(mm), 
radicality(R0/R1/R2) 
(12) Intraoperative complications (occurring from skin incision to skin closure) 
including: 
surgery-related complications: intraoperative hemorrhage and injury: A. Vascular 
injury: A vascular injury is defined as a blood vessel with either a blood vessel clamp or 
a titanium clamp closure and an intra-cavity suture or any other method to control the 
bleeding. B. Organ damage: maybe including diaphragmatic injury, esophageal injury, 
duodenal injury, colon injury, small intestine injury, spleen injury (excluding <1/3 
spleen ischemia), liver injury, pancreatic injury, gallbladder injury, kidney damage etc. 
C. Tumor rupture: tumor envelope Integrity damage 
air 
abdominal-related 
complications: 
high-blood 
carbonate, 
mediastinal 
emphysema, subcutaneous emphysema, air embolism, respiratory circulation instability 
caused by abdominal pressure. 
Anesthesia-related complications: Allergic reactions. 

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(13) Intraoperative death (occurring during the time period from skin cutting to skin 
stitching completion) regardless of reason. 
9.3.3 Postoperative management 
9.3.3.1 The use of prophylactic analgesics 
Continuous postoperative prophylactic intravenous analgesia is allowable but not 
mandatory within postoperative 48 hours; its dose, type and rate of infusion should be 
determined by the anesthesiologist according to clinical practices and specific patient 
conditions. The repeated use of prophylactic analgesics is not allowed beyond 48 hours 
after the end of surgery, unless it is judged necessary 
9.3.3.2 Fluid replacement and nutritional support 
Postoperative fluid infusion (including glucose, insulin, electrolytes, vitamins, etc.) 
or nutritional support (enteral/parenteral) will be performed based on  doctor’s 
experience and routine clinical practices and is not specified in this study. After oral 
feeding, it is allowable to stop or gradually reduce fluid infusion/nutritional support. 
9.3.3.3 Post-operative rehabilitation management 
Management methods of incision, stomach and abdominal drainage tube: Follow 
regular diagnosis and treatment approaches. Eating recovery time, diet transition 
strategies: Follow regular diagnosis and treatment approaches. 
9.3.3.4 Discharge standard 
Patients needed to meet the following criteria for discharge: 1) satisfactory intake 
of a soft diet. 2) move around of their bed. and 3) absence of complications by routine 
clinical examinations. This information will be recorded in the CRF. 
9.3.4 Postoperative observation items 
Definition of “postoperative day n”: One day from 0:00 to up to 24:00. Up to  
24:00 on the day of surgery is “postoperative day 0;” the next day from 0:00 to up to 
24:00 is “postoperative day 1;” and so on. From the first postoperative day  until 
hospital discharge, the research assistant should timely fill in the following items and 
specific observation items including: 
(1) Pathologic results： 
Original lesion tissue typing, Distant metastasis, and parts, NIH Hazard grading, 
Radical surgery degree (R0/R1/R2), The total number of lymph nodes, the number of 
lymph nodes in each group, the number of lymph node metastases in each group and the 
total number of metastases in pathological specimens were obtained 

Study protocol 
XIX
 
 
(2) Postoperative complications： 
Postoperative complications are divided into and short-term complications after surgery 
and long-term complications after surgery. Short-term is defined as within 30 days of 
surgery or the first discharge if the hospital days > 30 days. Long-term is defined as the 
period from 30 days or more after the operation, or the first discharge (the hospital days 
after surgery >30 days) to 3 years after the operation. 
Severity of complication is graded according to Clavien–dindo complication scoring system, 19 
IIIA level and above are serious complication 
Ⅰ: Any deviation from the normal postoperative course without the need for pharmacologic 
treatment or surgical, endoscopic, and radiologic interventions. Allowed therapeutic regimens 
are drugs as antiemetics, antipyretics, analgesics, and diuretics, and electrolytes and 
physiotherapy. This grade also includes wound infections opened at the bedside. 
Ⅱ：Requiring pharmacologic treatment with drugs other than such allowed for 
grade I complications. Blood transfusions and total parenteral nutrition are also included. 
Ⅲ：Requiring surgical, endoscopic, or radiologic intervention 
Ⅲa：Intervention not under general anesthesia 
Ⅲb：Intervention under general anesthesia 
Ⅳ ： Life-threatening complication (including CNS complications) requiring IC(intermediate 
care)/ICU(intensive care unit) 
management 
Ⅳa：Single organ dysfunction (including dialysis) 
Ⅳb：Multiple organ dysfunction 
Ⅴ：Death as a result of complications 
 
Classification and name of 
complication 
Diagnostic criteria 
Abdominal bleeding 
Intra-abdominal hemorrhage requires blood transfusion, emergency 
endoscopy or surgical intervention to eliminate anastomotic bleeding 
Anastomotic bleeding 
The postoperative gastrointestinal decompression tube continued to 
have fresh red blood outflow; the hemoglobin drops more than 1g/dL 
Gastrointestinal anastomotic 
stoma Fistula 
Using gastrointestinal angiography to see contrast agent leak out from 
the anastomosis, or the blue drainage outflow through tube after oral 
Methylene blue to eliminate the possibility duodenal stump fistula and 

Study protocol 
XX
 
 
intestinal fistula 
Duodenal Stump Fistula 
Using gastrointestinal angiography to see contrast agent leak out from 
the duodenal stump to eliminate the anastomotic fistula or intestinal 
fistula 
Intestinal fistula 
Using gastrointestinal angiography to see the blue drainage outflow 
through tube after oral Methylene blue to eliminate anastomotic fistula 
and duodenal stump fistula 
Stenosis of Anastomosis 
Endoscopic examination with a 9.2-mm endoscopy not passing through 
the anastomosis to eliminate recurrence of tumors 
Input jejunal loop obstruction 
Abdominal pain, abdominal distension, vomiting and other symptoms. 
Abdominal flat to see the right upper abdomen expansion of the 
intestinal loop, and there is a liquid plane, or a visible input loop 
jejunum giant expansion by barium meal examination. 
Intestinal obstruction after 
operation 
Abdominal X-ray shows a plurality of liquid planes and the 
phenomenon of intestinal effusion with visible isolated, fixed, swelling 
of the intestinal loop. Total Abdominal CT showed edema, thickening, 
adhesion of intestinal wall, accumulation of gas in intestinal cavity, 
uniform expansion of bowel and intra-abdominal exudation. 
Early dumping syndrome 
Combined the symptoms of sweating, heat, weakness, dizziness, 
palpitations, heart swelling feeling, vomiting, abdominal colic or 
diarrhea with the signs of tachycardia, blood pressure micro-rise, 
breathing a little faster sign after meal 15-30 minutes, and solid phase 
radionuclide gastric emptying scanning tips stomach quickly emptying. 
Late dumping syndrome 
Feeling hungry, flustered, out of sweating 2-3 hours after the meal . 
Blood sugar is less than 2.9mmol/L, excluding other diseases that 
cause hypoglycemia 
Intestinal 
ischemia 
and 
necrosis 
Under the digestive endoscopy, the intestinal mucosa congestion, 
edema, bruising, mucosal hemorrhage, the mucous membrane being 
dark red, the vascular network disappearing, can have part mucosal 
necrosis, following with mucosal shedding, ulcer formation with 
annular, longitudinal, snake and scattered in the ulcer erosion. 
Internal hernia 
Postoperative CT findings of cystic or cystic and solid mass, and 
intestinal aggregation, stretching, translocation, abnormal mesenteric 
movement, and thickening of the blood vessel. 
Alkaline reflux esophagitis 
1. Endoscopic examination and biopsy of the upper gastrointestinal 

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XX
 
 
 
tract showed evidence of inflammation of the mucous membranes and 
gastrointestinal metaplasia; 2. CT scan and gastrointestinal barium 
meal examination showed no expansion or obstruction of the input 
loop. 
Incision splitting 
Including partial dehiscence of the incision and full-layer dehiscence 
Incisional 
hernia 
of 
abdominal wall 
The swelling tumor showing in the surgical scar area or abdominal 
wall swelling when standing or force. CT shows ventral wall continuity 
interruption and hernia content extravasation 
Incision infection 
Thickening of the soft tissue at the incision, in or below the incision of 
gas, exudation, swelling of the incision or pus from the incision 
extrusion, or secretion culture of pathogenic bacteria. 
Lymphatic leakage 
A chyle test when abdominal drainage ﬂuid exceeded 300 ml/day for 5 
consecutive days after postoperative day 3. 
Pneumonia 
Complies with one of the following two diagnostic Criteria: 1. 
Auscultation/percussion voiced + one of the following: fresh sputum or 
sputum character changes; blood culture (+); bronchoalveolar lavage 
fluid, anti-pollution sample brush, biopsy specimens cultured 
pathogenic bacteria. 2. Chest film hints of new or progressive 
infiltration + one of the following: fresh sputum or sputum character 
changes, blood culture (+), bronchoalveolar lavage fluid, anti-pollution 
sample brush, biopsy specimens cultured pathogenic bacteria; isolate 
virus or detect IgM, IgG (+) of respiratory viral 
Acute pancreatitis 
Irritability, abdominal pain, anti-jumping pain, fever, leukocyte 
increase and blood amylase increased occuring and diagnosed by 
ultrasound or CT within 3 days after surgery. 
Acute cholecystitis 
Serum bilirubin exceeding 85μmol/l and ultrsound examination shows 
gallbladder enlargement, wall thickness, signal and sound shadow of 
gallbladder stone, bile internal sediment, gallbladder contraction bad 
etc. 
Pleural effusion/infection 
CT scan showed the localized fluid low density area of thoracic cavity, 
which could accompany with gas, and culture pathogenic bacteria in 
thoracic endocrine. 
Abdominal infection 
There is at least one of the following evidences in abdominal cavity 
within 30 days after operation: 1. discharge of pus, with/without 
microbiological examination; 2. bacterial culture positive; 3. diagnosed 
by detection, pathology, imaging findings. 

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XX
 
 
 
Pelvic infection 
Symptoms of systemic infection or rectal irritation, combined with a 
rectal finger examination and touching tenderness, or a married woman 
with a posterior vault to extract pus-based fluid 
Sepsis 
The following two conditions are available: 1. There is evidence of 
active bacterial infection, but the blood culture does not necessarily 
appear pathogenic bacteria; 2. meeting two of the following four items 
at the same time: (1). body temperature >39. 0℃ or ＜35.5 ℃ for 3 
consecutive days, (2). heart rate > 120 times/min; (3). total white blood 
cells >12. 0*109/L or <4.0*109/l, wherein neutrophils >0. 80, or naïve  
granular cells >0. 10; (4).Respiratory frequency > 28 times/min 
Urinary system infection 
Symptoms of urine frequency, urgency and urine pain etc. and urine 
bacteria culture colony count 1000~10 million/ml in the absence of 
antibiotics; No symptoms of urine frequency, urgency and urine pain 
etc, urine bacterial culture colony count ≥ 100,000/ml 
Pancreatic fistula 
The level of amylase in the drainage fluid is three times than normal 
level. 
Bile fistula 
Symptoms of abdominal distension, Abdominal pain, tenderness, anti-
jumping pain, muscle tension, abdominal puncture or drainage 
fluid for bile 
Celiac fistula 
The drainage fluid is milky white, and more than 200ml/d and and does 
not decrease for 48 hour, the celiac qualitative test is positive, and the 
level of triglyceride >110 mg/dL at the same time. 
Nutritional 
disorder 
after 
gastrectomy 
In the presence of weight loss, anemia, malnutrition bone disease, 
vitamin A deficiency and other symptoms, laboratory tests suggest that 
the intestinal absorption function test is abnormal, excluding other 
causes of nutritional disorders 
Bone 
disease 
after 
gastrectomy 
Lumbar back pain, length shortening, kyphosis, bone fractures and 
other symptoms. Bone density decreased combining with elevated 
alkaline phosphatase and serum calcium reduction, the concentration of 
serum 25-(O1) D3 and 1,25-(O1) 2D3 increasing and the serum 
parathyroid hormone increasing. Exclusion of bone disease caused by 
other causes. 
Subcutaneous emphysema 
visible the irregular speckle shadow under the skin in the horizontal 
flat sheet. 
Mediastinal emphysema 
In the posterior and anterior flat fame, a long narrow gas shadow rises 
to the  neck  soft  tissue along  the mediastinal  side, forming a thin-line 

Study protocol 
XX
 
 
 
dense shadow. In the lateral flat there was a visible and clear band 
between the heart and the sternum. The CT examination, if necessary, 
shows gas density line-like shadow around the mediastinal and 
mediastinal pleura closing to the direction of the lung field. 
Postoperative hemorrhage 
An amount of hemorrhage exceeding 300 ml. 
Postoperative 
cardiac 
dysfunction 
The symptom of snus tachycardia, sinus bradycardia, supraventricular 
tachycardia, ventricular tachycardia, and other arrhythmias, or heart 
failure preoperatively none-existing and postoperatively appearing,.and 
other causes of the above-mentioned manifestations are excluded. 
Hepatic dysfunction 
Bilirubin increasing and the levels of AST and ALT >5 times after 
operation and these symptoms no existing before sugery, 
Kidney function failure 
Postoperative continuing renal function insufficiency, blood creatinine 
rising 2mg/dl, or acute renal failure needing dialysis treatment. 
Cerebral embolism 
Acute onset, hemiplegia, aphasia and other focal neurological function 
deficits. Embolism site has low-density infarction, of which border is 
not clear and no obstructional performance within 24-48 hours after the 
onset. 
Pulmonary embolism 
Characteristics of dyspnea, chest pain, syncope, shortness of breath, 
right 
ventricular 
insufficiency 
and 
hypotension, 
pulmonary 
angiography revealed a filling defect. 
Venous thrombosis of lower 
extremities 
Local tenderness, swelling, purple skin color, combined with 
intravenous angiography to show the filling defect 
Mesenteric 
arterial 
embolization 
Patients with acute abdominal pain, vomiting, diarrhea, abdominal x-
ray of intestinal tract filling with gas or existing liquid level, 
abdominal angiography revealed a filling defect. 
DIC 
1.There are basic diseases easily leading to DIC, 2. There are more  
than two clinical performances: (1) severe or multiple bleeding 
tendencies; (2) Microcirculation disorder or shock cannot be explained 
by the original disease. (3) Extensive skin mucosal embolism, focal 
ischemic necrosis, shedding and ulcer formation, or unexplained lung, 
kidney, brain and another organ failure. (4) anticoagulant treatment.is 
effective. 3. The laboratory meets the following conditions: (1) there 
are 3 or more experimental abnormalities: platelet count, prothrombin 
time, activated partial coagulation enzyme time, thrombin time, 
fibrinogen level, D-two poly, and (2) difficult or special cases for 
special examination. 

Study protocol 
XX
 
 
 
Other 
Complications other than the above complications, which do not exist 
before surgery but appear after surgery 
 
(1) Blood test items (At postoperative day 1, 3, 5) 
Peripheral blood routine assessment: Hb, RBC, WBC, LYM, NEU, NEU%, and 
PLT、MONO； 
Blood biochemistry: Albumin, prealbumin, total bilirubin, AST, ALT, creatinine, 
urea nitrogen, fasting blood glucose, potassium, sodium, chlorine, calcium, CRP, IL-6, 
PCT, Blood amylase, ascites amylase. 
(2) Postoperative rehabilitation evaluation： 
Time to first ambulation (hours), time to first flatus (hour), time to liquid diet, time 
to removal of gastric tube (d), daily volume of gastric drainage (ml), time to removal of 
abdominal drainage tube (d), daily volume of drainage (ml).Blood transfusion volume 
(ml) from the end of surgery to postoperative discharge: a transfusion event is defined 
as infusion of the red blood cell suspension (ml) or whole blood (ml).Postoperative 
hospital stays (days): periods form surgery day to first discharge day 
9.4 Follow-Up 
9.4.1 Follow-up Period and strategy 
Follow-up visits will be completed by special persons for all cases selected in this 
study .All patients are followed up with 30 days, Recommend patient follow-up every 3 
months during the first 2 years and then every 6 months beyond the third year (1、 3、 
6、 9、 12、 15、18、21、24、30 and 36 months after the operation),and record with 
patients’ consent. This study suggests that the above examinations should be conducted 
in the patient's primary surgical research center, but does not exclude  outer court review. 
For Outer Court review, It recommended that visiting the hospital as a three-level 
hospital, and these information will be recorded by the follow-up specialist. The 
occurrence of tumor recurrence or metastasis and the survival status of all patients are 
evaluated and recorded according to the results of the various  examinations.  Patients 
who refuse to follow the protocol should be recorded as lost to follow-up, and  at the end 
of the study, these cases should be analyzed together with cases lost to follow-up in line 
with the criteria of this study. 

Study protocol 
XX
 
 
9.4.2 Assessment items during the follow-up 
(1) Systematic physical examination: 
The doctor in charge will regularly conduct a systematic physical examination at the 
time of each follow-up, giving particular attention to superficial lymph nodes, abdomen, 
and signs of metastases, among others. Meanwhile, ask about general conditions (Height, 
weight, BMI, diet). 
(2) Blood test items: 
Peripheral blood routine assessment: Hb、RBC、WBC、LYM、NEU、NEU%、
PLT、MONO 
Biochemistry: Albumin, pre-albumin, total bilirubin, Indirect bilirubin, direct 
bilirubin, AST, ALT, creatinine, urea nitrogen, Total cholesterol, triglycerides, fasting 
blood glucose, potassium, sodium, chlorine, calcium, serum tumor markers: CEA 、
CA19-9、CA72-4、CA12-5、AFP. 
(3) Imaging items: 
Recommend patient take imaging examination every 3 months during the first 2 years 
and then every 6 months beyond the third year (1、 3、 6、 9、 12、 15、18、21、24、
30 and 36 months after the operation). Including: Whole abdomen (including cavity) CT 
(thickness of 10 mm or less, in case of contrast agent allergy, CT horizontal scanning is 
only 
allowable or conversion to 
MRI). Upper gastrointestinal 
endoscopy 
(histopathological biopsy, endoscopic ultrasonography when necessary). Chest X-ray 
(AP and lateral views): lung field condition. Other means of evaluation: gastrointestinal 
radiography, ultrasonography of other organs, whole body bone scanning, and PET-CT, 
among others used at  physician’s discretion. 
9.5 Post-operative adjuvant therapy 
9.5.1 Indications for postoperative adjuvant chemotherapy 
After completion of the surgical treatment, according to the postoperative 
pathological results, subjects among the R0 resection cases that are stage II and above 
are administered postoperative adjuvant chemotherapy according to the provisions of 
this program.  
For cases of non-R0 resection or recurrence after R0 resection, this study does not 

Study protocol 
XX
 
 
stipulate the follow-up treatment plan; the research center decides on the action to be 
taken according to the clinical treatment routine. 
9.5.2 Postoperative adjuvant chemotherapy 
This study uses a combination of chemotherapy based on 5-FU (5-fluorouracil) 
and recommends the SOX regimen. 
In cases of good physical and tolerable conditions, chemotherapy is first started 
within 3-4 weeks after surgery and then according to the regularity of the chemotherapy 
cycle. 
During the chemotherapy period, tumor recurrence should be assessed  according 
to the follow-up plan. 
When tumor recurrence occurs during chemotherapy, the adjuvant chemotherapy 
regimen of this study is discontinued. The follow-up treatment is decided by the 
research center according to the clinical treatment routine. This study does not make 
regulations, but the cause and follow-up treatment plan should be recorded in the CRF. 
Adjuvant chemotherapy requires written approval from the patient. 
Subjects that refuse postoperative adjuvant chemotherapy or do not complete the 
adjuvant chemotherapy are not excluded from this study, but the cause is marked and 
recorded in the CRF. 
Patients who choose adjuvant chemotherapy, irregular chemotherapy, or a non-
first-line regimen are not excluded from the study, but Safety Evaluation Committee is 
obliged to monitor patient safety during follow-up. The patient's chemotherapy 
medication must be recorded in the CRF. 

Study protocol 
27 
 
 
9.5.3 Safety Evaluation Indicators of Postoperative Adjuvant Chemotherapy 
The safety evaluation indicators for patients enrolled in the study should be  immediately 
filled out by the investigators before and after each postoperative adjuvant chemotherapy 
cycle, with specific items including the following: 
(1) Performance Status (ECOG) 
(2) Subjective and objective status (according to the records of CTCAE v3.0 Short Name) 
(3) Blood tests: 
Peripheral venous blood assessment: Hb, RBC, WBC, LYM, NEU, NEU%, PLT, 
MONO. 
Blood biochemistry: albumin, prealbumin, total bilirubin, AST, ALT, creatinine, urea 
nitrogen, fasting blood glucose, serum tumor markers (CEA, CA19-9, CA72-4, CA12-5, 
AFP) 
(4) Safety evaluation items to be implemented during chemotherapy when necessary (refer to 
CTCAE v3.0): 
Neurotoxicity 
Cardiovascular system (cardiac toxicity, ischemic heart disease, etc.) 
Bone marrow suppression and infections due to immune dysfunction 
Others 
10 Statistical analysis 
10.1 Statistical analysis plan 
• Statistical software: we will use SPSS statistical software, version 23.0 (SPSS Inc), 
and the R software environment (R Foundation for Statistical Computing) to perform 
statistical analyses. 
• Basic principle：The method of differential testing was adopted. The safety population 
of the study consists of the patients who receive safety evaluation data after the 
intervention. Descriptive statistics and two-sided tests were conducted for the 
safety indicators and the incidence of adverse reactions. A p-value <0.05 is 
considered statistically significant. The confidence interval of the parameters is 
estimated with a 95% confidence interval. 
• 
Shedding analysis: Total shedding rate of two groups and loss rate due to adverse 
events will be compared using pearsonχ2 test 

Study protocol 
28 
 
 
•  All data analyses will be conducted on a per-protocol (PP) basis. 
• 
Method of outlier determination: the observation value is greater than P75 or less 
than P25, and the exceed value more than 3 times of the quartile spacing (=p75-
p25), which will be sentenced to outlier data. During the analysis, the sensitivity 
analysis is used for outlier data, namely analyzing outcomes including or excluding, 
outlier’s data. and if the results are not contradictory, the data is retained; if the 
contradiction, it depends on the specific circumstances. 
• Descriptive statistics: The measurement data gives the mean, the standard deviation 
and the confidence interval, and the minimum value, the maximum value, the P25, 
the median and the P75 are given when necessary; matched data also gives the 
mean and standard deviation of the gap-value, and the median and average rank of 
the Non-parametric method. The nominal-scale data gives the frequency 
distribution and the corresponding percentages. The level data gives the frequency 
distribution and the corresponding percentages, as well as the median and the 
average rank. Qualitative data give positive rate, positive number, and  
denominator numbers. The survival data gives the number of events, the number  
of deletions, the median survival time, and the survival rate. 
• 
Subgroup analysis ： Sub-group analysis is to find the factors that may affect 
prognostic according to the specific circumstances of the data。 
• Missing values handling：This study does not fill in missing values 
• 
Safety analysis: counting adverse responds incidence and incidence of adverse 
events and make a list to describe the adverse events occurring in the study. 
describe the results of the laboratory tests before and after the normal/abnormal 
changes and the relationship between the abnormal changes and drugs in the 
research, and make a list on the "normal/abnormal" changes occurred in the study.. 
More detailed statistical analysis is shown in the statistical analysis plan. 
11 Data management 
11.1 Case Report Form (CRF) 

Study protocol 
29 
 
 
11.1.1 CRF Types and Submission Deadline 
CRFs used in this study and their submission deadlines are as follows: 
(1) Case Screening: 1-7 days prior to surgery (time frame of three days) 
(2) Enrolling: submitted to the data center at one day prior to surgery 
(3) Surgery: within 1 day after surgery 
(4) Postoperative discharge: within three days after the first discharge 
(5) Follow-up records: 7 days after each specified follow-up time point 
11.1.2 Method of transmission of CRF 
In this study, the paper CRF form are used for information and data transmittal. 
11.1.3 Revision of CRF 
After the start of the study, if the CRF is found to lack items that are then deemed 
pertinent, under the premises of ensuring the amendment of the CRF does not cause 
medical and economic burden and increased risks to the selected patients, the CRF can 
be modified after the Research Committee adopt it through discuss at the meeting. If  
the amendment of the CRF requires no changes to this study protocol, the latter will not 
be modified. 
11.2 Monitoring and Supervising 
To assess whether study implementation follows protocol and data are being 
collected properly, monitoring should be conducted every February during the follow-
up period. Monitoring is to complete through visiting a hospital and comparing the 
original Data. 
12 Relevant Provisions on adverse events 
12.1 Various forms of adverse events caused by original incidence 
Adverse events relating to various forms of deterioration in primary diseases should be 
recorded according to Short Name of CTCAEv4.0. 
12.2 Evaluation of adverse events 
• Evaluation of adverse event/adverse reaction are based on[Accordion Severity 
Grading System] and [CTCAE v4.0]. 
• 
Adverse events will be graded 1 ~ 5 as per definition. For treatment-related 
death, fatal adverse events are classified as Grade 5 in the original CTCAE 
• 
Toxicity items specified in the [surgery-related adverse events], Grade and the 
discovery date of Grade should be recorded in the treatment process report. For other 
toxicity items observed, observed Grade 3 toxicity items are only recorded in the 

Study protocol 
30 
 
 
freedom registration column of the treatment process report, as well as Grade and the 
discovery date of Grade. Grade recorded in the treatment process report must be 
recorded in the case report form. 
• CTCAE v4.0, the so-called “Adverse Event”, “all observed, unexpected bad signs, 
symptoms and diseases (abnormal value of clinical examination are also included) in  
the treatment or disposal, regardless of a causal relationship with the treatment or 
handling, including determining whether there is a causal relationship or not”. 
• 
Therefore, even if events were “obviously caused by primary disease (cancer)” or 
caused by supportive therapy or combination therapy rather than the study regimen 
treatment (protocol treatment), they are “adverse events”. 
• 
For adverse event data collection strategy, the following principles should be 
complied with in this study:1) Adverse events within 30 days from the last treatment 
day of the study regimen treatment (protocol treatment), regardless of the presence or 
absence of a causal relationship should be completely collected. (When adverse events 
are reported, the causality and classification of adverse events are separately discussed) 
2) Adverse events within 30 days from the last treatment day of the study regimen 
treatment (protocol treatment), regardless of the presence or absence of a causal 
relationship should be completely collected. (When adverse events are reported, the 
causality and classification of adverse events are separately discussed) 
12.3 Reporting of Adverse Events 
• When “severe adverse events” or “unexpected adverse events” occur, the Research 
Responsible Person of research participating unit should report them to the 
Research Committee. 
•  Based on the relevant laws and regulations, adverse events should be reported to the 
province (city) Health Department at the location of the research center. Severe 
adverse events based on clinical research-related ethical guideline should be 
reported to the person in overall charge of the medical institution. The appropriate 
reporting procedures should be completed in accordance with the relevant 
provisions of all medical institutions at the same time. The person in charge of 
research of the research participating unit should hold accountability and 
responsibility for the emergency treatment of patients with any degree of adverse 

Study protocol 
31 
 
 
events to ensure patient safety. 
12.3.1 Adverse Events with Reporting Obligations 
12.3.1.1 Adverse Events with Emergency Reporting Obligations 
Any of the following adverse events should be reported on an emergent basis: 
• All patients who die during the course of treatment or within 30 days from the 
last treatment day, regardless of the presence or absence of a causal relationship 
with the study regimen treatment. Also, cases of discontinuation of treatment, even if 
within 30 days from the last treatment day, those patients are also emergent reporting 
objects. (“30 days” refers to day 0, the final treatment day, 30 days starting from the 
next day) 
• Those patients with unexpected Grade 4 non-hematologic toxicity (CTCAE v3.0 
adverse events other than the blood/bone marrow group), having a causality of 
treatment (any of definite, probable, possible) who emergent reporting objects 
are. 
12.3.1.2 Adverse Events with Regular Reporting Obligations 
One of the following adverse events are regular reporting objects: 
(1) After 31 days from the last treatment day, deaths for which a causal relationship 
with treatment cannot be denied, including suspected treatment-related death; death due 
to obvious primary disease is included. 
(2) Expected Grade 4 non-hematologic toxicity (CTCAE v3.0 adverse events other than 
the blood/bone marrow group). 
(3) Unexpected Grade 3adverse events: Grade 3 adverse events are not recorded in the 
12.1 expected adverse events. 
(4) Other significant medical events: adverse events that the study group deems cause 
Important and potentially permanent, significant impact on their offspring (MDS 
myelodysplastic syndrome, except for secondary cancer) Adverse events among above 
(2)-(4), determined to have a causal relationship (any of definite, probable, possible) 
with the study regimen are regular reporting objects. 
12.3.2 Reporting Procedure 
12.3.2.1 Emergency Reporting 
• In case of any adverse event on emergency study reporting objects, the doctor in 
charge will quickly report it to the Research Responsible Person of the research 
participating hospitals. When the Research Responsible Person of the hospital 
cannot be contacted, the coordinator or the doctor in charge of the hospital must 

Study protocol 
32 
 
 
assume the responsibility on behalf of the Research Responsible Person of the 
hospital. 
• First Reporting: Within 72 hours after the occurrence of adverse events, the 
Research Responsible Person of the hospital should complete the “AE/AR/ADR 
first emergency report” and send it to the Research Committee by email and 
telephone. 
• Second Reporting: The research responsible person of the research participating 
hospital completes the “AE/AR/ADR Report” and a more detailed case 
information report (A4 format), and then faxes the two reports to the Research 
Committee within 15 days after the occurrence of adverse events. If any autopsy 
examination, the autopsy result report should be submitted to the Research 
Committee. 
12.3.2.2 General Reports 
•  The research responsible person of research participating hospital completes the 
“AE/AR/ADR report”, and then faxes it to the Research Committee within 15 days 
after the occurrence of adverse events. 
12.5 Review of Efficacy and Safety Evaluation Committee 
The Efficacy and Safety Evaluation Committee reviews and discusses the report in 
accordance with the procedures recorded in the Clinical Safety Information 
Management Guideline, and makes recommendations in writing for the Research 
Responsible Person, including whether to continue to include study objects or to 
modify the study protocol. 

Study protocol 
33 
 
 
13 Ethical Considerations 
13.1 Responsibilities of researchers 
The investigators are responsible for the conduction of this study. The  
investigators will ensure the implementation of this study in accordance with the study 
protocol and in compliance with the Declaration of Helsinki, as well as domestic and 
international ethical guiding principles and applicable regulatory requirements. It is 
specially noted that, the investigators must ensure that only subjects providing informed 
consent can be enrolled in this study. 
13.2 Information and Informed Consent of Subjects 
An unconditional prerequisite for subjects to participate in this study is his/her 
written informed consent. The written informed consent of subjects participating in this 
study must be given before study-related activities are conducted. 
Therefore, before obtaining informed consent, the investigators must provide 
sufficient information to the subjects. In order to obtain the informed consent, the 
investigators will provide the information page to subjects, and the information required 
to comply with the applicable regulatory requirements. While providing written 
information, the investigators will orally inform the subjects of all the relevant 
circumstances of this study. In this process, the information must be fully and easily 
understood by non-professionals, so that they can sign the informed consent form 
according to their own will on the basis of their full understanding of this study. 
The informed consent form must be signed and dated personally by the subjects 
and investigators. All subjects will be asked to sign the informed consent form to prove 
that they agree to participate in the study. The signed informed consent form should be 
kept at the research center where the investigator is located and must be properly safe 
kept for future review at any time during audit and inspection throughout the inspection 
period. Before participating in the study, the subjects should provide a copy of signed 
and dated informed consent form. 
At any time, if important new information becomes available that may be related  
to the consent of the subjects, the investigators will revise the information pages and 
any other written information which must be submitted to the IEC/IRB for review and 
approval. The revised information approved will be provided to each subject 
participating the study. The researchers will explain the changes made to the previous 
version of ICF to the subjects 

Study protocol 
34 
 
 
13.3 Identity and Privacy of Subjects 
After obtaining an informed consent form, each selected subject is assigned a 
subject number (Allocation Number). This number will represent the identity of the 
subject during the entire study and for the clinical research database of the study. The 
collected data of subjects in the study will be stored in the ID. 
Throughout the entire study, several measures will be taken to minimize any 
breaches of personal information, including: 1) only the investigators will be able to 
link to the research data of the subjects to themselves through the identify table kept at 
the research center after authorization; 2) during onsite auditing of raw data by the 
supervisors of this study, as well as relevant inspection and inspection visits by the 
supervision   departments, the personnel engaging  in the above activities may view    
the original medical information of subjects that will be kept strictly confidential. 
Collection, transmission, handling and storage of data on study subjects will 
comply with the data protection and privacy regulations. This information will be 
provided to the study subjects when their informed consent is being obtained for 
treatment procedures in accordance with national regulations. 
13.4 Independent Ethics Committee or Institutional Review Committee 
Before beginning the study, the research center will be responsible for submitting 
the study protocol and relevant documents (informed consent form, subject information 
page, CRF, and other documents that may be required) to the Independent Ethics 
Committee (IEC)/ Institutional Review Board (IRB) to obtain their favorable 
opinion/approval. The favorable opinions/approval documents of the IEC/IRB will be 
archived in the research center folders of the investigators. 
Before beginning the study at the center, the investigators must obtain written 
proof of favorable opinions/approval by the IEC/IRB, and should provide written proof 
of the date of the favorable opinions/approval meeting, written proof of the members 
presenting at the meeting and voting members, written proof of  recording  the  
reviewed study, protocol version and Informed Consent Form version, and if possible, a 
copy of the minutes. 
In case of major revisions to this study, the amendment of the study protocol will 
be submitted to the IEC/IRB prior to performing the study. In the course of the study, 
the relevant safety information will be submitted to the IEC/IRB in accordance with 
national regulations and requirements. 

Study protocol 
35 
 
 
13.5 Supervising 
The research approach of the authorities and any associated files (such as the 
research protocol, subjects’ informed consent) will be in accordance with the 
requirements of the ethical review board of biomedical research involving humans 
(Trial) (2007) and the applicable Chinese laws and regulations. Studies should provide 
the main references or inform the ethics review guidance advisory organization of the 
provincial health administrative department in the province the research center is in. 
 
14 Organizations and Responsibilities of Study 
14.1 Research Committee 
⚫ Responsible for developing study protocol, auditing eligibility for inclusion and 
guiding the interpretation of informed consent; also responsible for the collection  
of adverse event reports, guiding the clinical diagnosis and treatment of such events 
and the emergency intervention of serious adverse events. 
⚫ Person in Charge of Research Committee: Peiwu Yu (Department of General 
Surgery and Center of Microinvasive Gastrointestinal Surgery,Southwest Hospital, 
China) 
Add: Gaotanyan Main Street 29, Shapingba District, Chongqing 400038, China  
Telephone: +86-023-68754161, Fax: +86-023-68754161； 
E-mail:yupeiwu01@sina.com 
14.2 Efficacy and Safety Evaluation Committee 
Responsible for the supervision/monitoring of treatment safety and efficacy of this 
study. 
⚫ Person in Charge of Efficacy and Safety Evaluation Committee: Peiwu Yu 
(Department of General Surgery and Center of Microinvasive Gastrointestinal 
Surgery,Southwest Hospital, China) 
14.3 Independent Ethics Committee/Institutional Review Board (IEC/IRB) 
Responsible for evaluating this study to determine if risks to which subjects are 
exposed have been duly minimized and whether these risks are reasonable compared to 
expected benefits. 
IRB number: KY201810 

Study protocol 
41 
 
 
15 References 
[1] Chen W, Zheng R, Baade P D, et al. Cancer statistics in China, 2015[J]. CA: A Cancer 
Journal for Clinicians,2016,66(2):115-132. 
 [2] Ahmad S A, Xia B T, Bailey C E, et al. An update on gastric cancer[J]. Current Problems in 
Surgery,2016,53(10):449-490. 
 [3] Liu K, Yang K, Zhang W, et al. Changes of Esophagogastric Junctional Adenocarcinoma 
and Gastroesophageal Reflux  Disease Among Surgical Patients During 1988-2012: A Single-
institution, High-volume Experience in China[J]. Ann Surg,2016,263(1):88-95. 
 [4] Torre L A, Siegel R L, Ward E M, et al. Global Cancer Incidence and Mortality Rates and 
Trends--An Update[J]. Cancer Epidemiology Biomarkers & Prevention,2016,25(1):16-27. 
 [5] Japanese gastric cancer treatment guidelines 2014 (ver. 4)[J]. Gastric Cancer,2017,20(1):1-
19. 
 [6] Hu Y, Huang C, Sun Y, et al. Morbidity and Mortality of Laparoscopic Versus Open D2 
Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial[J]. J Clin 
Oncol,2016,34(12):1350-1357. 
 [7] Inaki N, Etoh T, Ohyama T, et al. A Multi-institutional, Prospective, Phase II Feasibility 
Study of Laparoscopy-Assisted Distal Gastrectomy with D2 Lymph Node Dissection for Locally 
Advanced Gastric Cancer (JLSSG0901)[J]. World J Surg,2015,39(11):2734-2741. 
 [8] Haverkamp L, Weijs T J, van der Sluis P C, et al. Laparoscopic total gastrectomy versus 
open total gastrectomy for cancer: a systematic review and meta-analysis[J]. Surgical 
Endoscopy,2013,27(5):1509-1520. 
 [9] Etoh T, Honda M, Kumamaru H, et al. Morbidity and mortality from a propensity score-
matched, prospective cohort study of laparoscopic versus open total gastrectomy for gastric cancer: 
data from a nationwide web-based database[J]. Surg Endosc,2017. 
[10] Chen X Z, Wang S Y, Wang Y S, et al. Comparisons of short-term and survival outcomes 
of laparoscopy-assisted versus open total gastrectomy for gastric cancer patients[J]. 
Oncotarget,2017,8(32):52366-52380. 
[11] Bo T, Peiwu Y, Feng Q, et al. Laparoscopy-assisted vs. open total gastrectomy for 
advanced gastric cancer: long-term outcomes and technical aspects of a case-control study[J]. J 
Gastrointest Surg,2013,17(7):1202-1208. 
[12] Oleynikov D. Robotic Surgery[J]. Surgical Clinics of North America,2008,88(5):1121-1130. 
[13] Junfeng Z, Yan S, Bo T, et al. Robotic gastrectomy versus laparoscopic gastrectomy for 
gastric cancer: comparison of surgical performance and short-term outcomes[J]. Surgical 

Study protocol 
42 
 
 
Endoscopy,2014,28(6):1779-1787. 
[14] Kim H I, Han S U, Yang H K, et al. Multicenter Prospective Comparative Study of Robotic 
Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma[J]. Ann Surg,2016,263(1):103-109. 
[15] Coratti A, Fernandes E, Lombardi A, et al. Robot-assisted surgery for gastric carcinoma: 
Five years follow-up and beyond: A  single western center experience and long-term oncological 
outcomes[J]. Eur J Surg Oncol,2015,41(8):1106-1113. 
[16] Yoon H M, Kim Y W, Lee J H, et al. Robot-assisted total gastrectomy is comparable with 
laparoscopically assisted total gastrectomy for early gastric cancer[J]. Surg Endosc,2012,26(5):1377-
1381. 
[17] Son T, Lee J H, Kim Y M, et al. Robotic spleen-preserving total gastrectomy for gastric 
cancer: 
comparison 
with 
conventional 
laparoscopic 
procedure[J]. 
Surgical 
Endoscopy,2014,28(9):2606-2615. 
 
 
16.Annex 
16.1Informed Consent Form 
 
Informed Consent · Informed Notification page  
（Vision：2.0   Date of edition: 2018.01.08） 
Dear patient： 
   You have been diagnosed with                    .We are currently carrying out research and will perform robotic radical 
gastrectomy or laparoscopic radical: Safety and feasibility between Robotic and laparoscopic D2 radical total 
gastrectomy for locally advanced gastric cancer(NCT03500471).Robotic-assisted or laparoscopic gastrectomy to 
treat your disease according to your will. The clinical study protocol has been submitted to the Medical Ethics Committee 
of Southwest Hospital for review and approval. 
Before you decide whether or not to participate in this clinical study, please read the following as carefully as 
possible.It can help you understand the clinical study, why the clinical study was conducted, the procedure and duration of 
the study.If you wish, you can discuss it with your relatives, friends, or ask your doctor for an explanation to help you 
make a decision. 
1、Clinical background and purpose 
1.1 Current status of disease treatment: Although many advances have been made in treatment, radical surgery is 
still the main treatment method for the gastric. At present, total gastrectomy with D2 Lymphadenectomy is the standard 
surgical method for advanced gastric cancer such as upper stomach and esophagogastric junction carcinoma. The surgical 
methods can be divided into open surgery and minimally invasive surgery. Minimally invasive surgery has the advantages 
of less trauma, less bleeding, less postoperative pain, faster recovery, less complications and so on. It has been widely used 
at home and abroad and achieved good clinical results. Minimally invasive surgery includes laparoscopic surgery and 
robotic surgery. 
1.2 Objective: In this study, A prospective cohort study was conducted to compare and observe the differences 
between robotic-assisted radical gastrectomy and laparoscopic surgery for advanced gastric cancer in terms of surgical 
efficacy and postoperative complications. Therefore, the safety and efficacy of the operation were evaluated scientifically, 
providing evidence based medicine for its extensive development. 
1.3 Your current treatment options: Radical gastrectomy is the main method for the treatment of advanced gastric 
cancer, and the surgery should meet the requirements of D2 radical gastrectomy. At present, the minimally invasive 

Study protocol 
43 
 
 
surgical methods you can choose include robotic-assisted D2 radical gastrectomy and laparoscopic D2 radical gastrectomy. 
2、Who should not participate in a clinical study 
1.Patients with early gastric cancer； 
2.Age<18 years or Age>80 years； 
3. radical total gastrectomy with D2 Lymphadenectomy is not required； 
4..Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including those 
surrounding important vessels  
5.Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer  
Previous 
upper abdominal 
surgery (except laparoscopic cholecystectomy) 
6.Previous neoadjuvant chemotherapy or radiotherapy 
7.Unstable myocardial 
infarction, 
angina, or 
cerebrovascular accident within the past 6 months 
8.FEV1＜50% of predicted values 
9.Other malignant diseases 
10.Severe mental disorder 
11.Women during breast-feeding or pregnancy 
3、What will you do if participate in a clinical study？  
1．A total of 150 people will be included in this study for 3 years. Before you are enrolled in the clinical study, the 
doctor will ask and record your medical history, and perform blood routine examination, Blood biochemistry, Serum tumor 
markers, gastroscopy, upper abdominal CT and other examinations. If you meet the inclusion and exclusion criteria, you 
may voluntarily participate in the clinical study and sign an informed consent form. 
If you do not wish to participate in the clinical study, we will treat you as you wish. 
 
2. If you volunteer to participate in the clinical study, you will follow the following steps： 
1) You have accepted our initial screening after admission and are a candidate for inclusion in this clinical study. We will 
inform you and your family members of the details of this clinical study in detail and answer all your questions. Please 
sign the informed consent for this clinical study after you confirm that you are fully informed of all the contents of this 
clinical study. 
2) At the same time, you will be asked to fill in detailed personal information. We will make every effort to protect the 
privacy of your personal information within the scope permitted by law. 
3) According to the medical operation routine, decide whether to adopt robotic-assisted radical gastrectomy or 
laparoscopic radical gastrectomy according to your will. You and your family will be informed and signed the 
informed consent for surgery. 
4) After the operation, we will carefully observe and record your recovery, and inform you or your family members of 
your condition in time. At the same time, we also need your cooperation to complete some necessary examinations. 
5) After the operation, we will further determine whether you will receive chemotherapy according to the pathological 
diagnosis. During this period, we will carefully observe and record your various symptoms and signs, and actively deal 
with your various post-chemotherapy discomfort. 
6) Postoperative follow-up plan: The first follow-up will be conducted 1 month after the operation. The follow-up doctor 
will perform physical examination, and the related laboratory tests mainly include blood routine examination, Blood 
biochemistry, Serum tumor markers, etc. If necessary, upper abdominal enhanced CT examination, chest X-ray 
examination, gastroscopy examination, etc. At the same time, the postoperative quality of life was assessed by 
international standards EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22. 
3. Other matters that require your cooperation 
You should go to the hospital according to the appointment of the doctor and you (during the follow-up period, the doctor 
may call or visit you to learn about your situation).Your follow-up is important because your doctor will determine whether the 
treatment you are receiving is really working and will guide you in a timely manner. 
If you need additional treatment, please contact your doctor. 
4、Possible benefits of participating in this clinical study 
You will not benefit from this study, but the relevant data and information obtained from this study will provide a more 
reliable evidence-based medical basis for the treatment of delayed gastric cancer with total gastrectomy to benefit future patients. 
5、Possible adverse reactions, risks and inconveniences of participating in this clinical study 

Study protocol 
44 
 
 
We will enter the robotic or laparoscopic group as you wish.The possible risks, adverse reactions, and various surgical 
complications of the patients in any surgical group cannot be completely prevented by the current medical level, and we will 
inform them in detail in the form of surgical informed consent before surgery. 
If you experience any discomfort, deterioration of illness, or any unexpected situation during the clinical study, whether 
related to surgery, you should inform your doctor promptly, who will make a judgment and give appropriate medical attention. 
You should go to the hospital on time, which takes up some of your time, but also may cause trouble or inconvenience to 
you. 
6、Terms for expenses and damages 
1. expenses 
Both of the two surgical methods are commonly used in clinical practice. Follow-up is also required in routine medical 
treatment, and the corresponding costs should be borne by you. 
The possible cost of laparoscopic surgery is about ¥90,000, and that of robotic surgery is about ¥110,000. If there are 
complications related to surgery and anesthesia, the treatment costs will increase. 
Postoperative follow-up and examination items were all routine items after gastric cancer surgery, and the costs should be 
paid by the patients themselves. 
We will provide you with health consultation related to gastric cancer, physical examination and quality of life evaluation 
according to the follow-up requirements, and may give you follow-up by phone or letter. 
You need to pay for the treatment and examination of other diseases you have combined. 
2. Injury compensation clause 
If there is any damage related to this study, we will compensate in accordance with the relevant requirements of 
relevant laws and regulations of the people's Republic of China (the operation risk of the two operation methods is not 
considered as the research risk of this study)。 
7、Is personal information confidential? 
    Your medical records (surgical records, examination results, etc.) will be completely kept in the hospital. The doctor will 
record the test results on your medical record. The surgeon and ethics committee will be allowed to access your medical 
records. Any public report on the results of this clinical study will not disclose your personal identity. We will make every 
effort to protect the privacy of your personal medical data to the extent permitted by law. 
8、How to get more information? 
    You can ask any questions about this clinical study at any time and get the corresponding answers. 
If there is any important new information during the clinical study that may affect your willingness to continue to 
participate in the clinical study, your doctor will inform you in time. 
If you have any questions about the procedure of this study, you can consult Dr. Li Pingang at (023) 68754167. If 
you have any questions about your rights and interests to participate in this study, you can consult the ethics committee of 
southwest hospital of China at (023) 68754814. 
9、Voluntarily choose to participate in clinical research and withdraw from clinical research 
    Whether to participate in the clinical study depends entirely on your wishes. Participation in this study will not have any 
therapeutic impact on you. You may refuse to participate in this clinical study or withdraw at any time during the clinical 
study, which will not affect the relationship between you and the doctor, nor will it affect the loss of your medical 
treatment or other interests. 
For your best interests, the doctor or surgeon may suspend you from continuing to participate in the clinical study at any 
time during the clinical study. 
This test will be aborted or withdrawn if:： 
1. Patients intraoperatively/postoperatively confirmed as T4b. 
2. tumor confirmed intraoperatively or postoperatively: distant metastasis only found by intraoperative exploration or 
postoperative pathological biopsy or a positive postoperative peritoneal lavage cytology examination. 
3.Requirement of simultaneous surgery for other diseas. 
4.Patients intraoperatively confirmed as unable to complete D2 lymph node dissection/R0 resection due to tumor: unable to 
complete R0 resection due to regional lymph node integration into a mass or surrounded with important blood vessels, which cannot be 
resected. 
5.Sudden severe complications during the perioperative period (intolerable surgery or anesthesia), which renders it 
unsuitable or unfeasible to implement the study treatment protocol as scheduled. 
6.Patients who voluntarily quit or discontinue treatment for personal reasons at any stage after inclusion in this study. 
7.Treatment implemented is proven to violate study protocol. 
    If you withdraw from the clinical study for any reason, you will proceed to the next step under the guidance of your 

Study protocol 
45 
 
 
doctor. 
10、What should you do now? 
    Whether to participate in this clinical study is up to you (and your family). 
Before you make a decision to participate in the clinical study, please ask your doctor as many questions as possible. 
Thank you for reading the above materials. If you decide to participate in this clinical study, please tell your doctor and he 
/ she will arrange all matters related to the clinical study for you. Please keep this information. 
 
 
 
 
Informed consent· Signature page 
（Date of edition：2018.01.08） 
Title of clinical study：Safety and feasibility between Robotic and laparoscopic D2 radical total 
gastrectomy for locally advanced gastric cancer:A prospective cohort study 
 
Declaration of consent: 
I have read the above introduction about this clinical study, and have the opportunity to discuss and ask questions 
with doctors about this clinical study. All my questions were answered satisfactorily. 
I know the possible risks and benefits of participating in this clinical study. I know that participating in the clinical 
study is voluntary. I confirm that I have had enough time to consider this and understand that: 
I can always ask the doctor for more information. 
I can withdraw from this clinical study at any time without discrimination or retaliation, and my medical treatment 
and rights will not be affected. 
I also know that if I withdraw from clinical research halfway, I will tell the doctor about the changes of my condition 
and complete the corresponding physical and chemical examination, which will be very beneficial to the whole condition. 
If I need to take any other treatment due to the change of my condition, I will consult the doctor in advance or tell the 
doctor truthfully afterwards. 
I agree with the ethics committee or its representative to access my clinical research data. 
I will receive a signed and dated copy of the informed consent form. 
Finally, I decided to agree to participate in this clinical study and promise to follow the doctor's advice as much as 
possible. 
 
Participant signature：                                    Date: ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿  
Legal representative：                                     Date: ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿  
Relationship with participant：                          
Phone number：                            
 
 
I confirm that I have explained the details of this clinical study to the patient, including its rights, possible benefits 
and risks, and gave him a copy of the signed informed consent form. 
Doctor signature：                                 Date: ＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿  
Phone number：                            
 
 
 

Study protocol 
46 
 
 
16.2Definitions involved in SOP 
16.2.1 ECOG performance status score 
 
According to the simplified performance status score scale developed by the ECOG, the 
patients’ performance status can be classified into 6 levels, namely 0-5, as follows: 
0: Fully active, able to carry on all pre-disease performance without restriction 
1: Restricted in physically strenuous activity but ambulatory and able to carry out work of 
a light or sedentary nature, e.g., light housework, office work 
2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up 
and about more than 50% of waking hours 
3: Capable of only limited self-care, confined to bed or chair more than 50% of waking 

Study protocol 
47 
 
 
hours 
4: Completely disabled. Cannot carry on any self-care. In total, confined to bed or chair 
5: Dead 
Patients at levels 3, 4 and 5 are generally considered to be unsuitable for surgical treatment 
or chemotherapy. 
16.2.2 ASA classification 
According to the patients' physical status and surgical risk before anesthesia, the American 
Society of Anesthesiologists (ASA) has categorized patients into 5 levels (I-V levels): 
Class I: Well-developed patients with physical health and normal function of various 
organs, with a perioperative mortality rate of 0.06% -0.08%. 
Class II: Patients with mild complications and good functional compensation in addition to 
surgical diseases, with a perioperative mortality rate of 0.27% -0.40%. 
Class III: Patients with severe complications and restricted physical activity but still 
capable of coping with day-to-day activities, with a perioperative mortality rate of 1.82% 
-4.30%. 
Class IV: Patients with serious complications who have lost the ability to perform day-to-
day activities, often have life-threatening conditions, and a perioperative mortality rate of 7.80% 
-23.0%. 
Class V: Moribund patients either receiving surgery or not, have little chance for survival, 
and a perioperative mortality rate of 9.40% -50.70%. 
Generally, Class I/II patients are considered good for anesthesia and surgical tolerance, 
with a smooth anesthesia process. Class III patients are exposed to some anesthesia risks; 
therefore, good preparations should be fully made before anesthesia, and effective measures 
should be taken to prevent potential complications during anesthesia. Class IV patients are 
exposed to the most risks, even if good preoperative preparations are made, and have a very 
high perioperative mortality rate. Class V patients are moribund patients and should not  
undergo an elective surgery. 
16.2.3 Oncology-related definitions 
In this study, tumor staging is based on AJCC-8; surgical treatment follows the Japanese Gastric 
Cancer Treatment Guidelines, Physicians Edition, 4rd Edition, 2014.05, and other writing and 
recording principles follow the Japanese Gastric Cancer Statute 15th. 
16.2.4 Primary focus location 
The greater and lesser curvature of the stomach are divided into three equal parts, the U (upper), 
M (middle) and L (lower) areas, connected to the corresponding points. If the lesions are located 

Study protocol 
48 
 
 
in two or more adjacent areas, they should be recorded in the order of the main portions of the 
lesions. Esophagogastric junction carcinoma is defined as a tumor whose tumor center is 
located within 5cm above and below the esophagogastric junction. According to Siewert 
classification, the tumor was divided into Siewert type I : the tumor center was located 1 
~ 5 cm above the esophagogastric boundary; Siewert type II : The center of the tumor 
was 1 cm to 2 cm above the esophagogastric boundary.Siewert type III : The tumor 
center is located 2 to 5 cm below the esophagogastric boundary. 
 
 
 
Fig. 3. Siewert type 
16.2.5 Tumor staging record 
16.2.5.1 Recording principle 

Study protocol 
49 
 
 
The two staging records for clinical classification and pathological classification involve T 
(invasion depth), N (regional lymph node) and M (distant metastasis), which are expressed in 
Arabic numerals and denoted as x if indefinite. 
 
 
 
 
 
 
 
 
 
 
 
16.2.5.2 Records of tumor invasion depth 
Tumor invasion depth is defined as follows: 
TX: Unknown cancer invasion depth 
T0: No cancer found 
T1: Cancer invasion is only confined to the mucosa (M) or the submucosal tissue (SM) 
◆ 
T1a: Cancer invasion is only confined to the mucosa (M) 
Clinical classification 
Pathological classification 
Physical examination X-ray, endoscopy, 
diagnostic imaging 
laparoscopy, 
intraoperative 
observations 
(laparotomy/laparoscopy), biopsy, cytology, 
biochemistry, biology examination 
Pathological diagnosis of the 
endoscopic/surgical specimens 
Intraperitoneal exfoliative cytology 

Study protocol 
50 
 
 
◆ 
T1b: Cancer invasion is confined to the submucosal tissue (SM) 
 
T2: Cancer invasion exceeds the submucosal tissue but is only confined to the inherent 
muscular layer (MP) 
T3: Cancer invasion exceeds the inherent muscular layer (MP) but is only confined to the 
subserosal tissue (SS) 
T4: Cancer invasion involves the serosa (SE) or direct invasion of adjacent structures (SI) 
◆ 
T4a: Cancer invasion involves only the serosa (SE) 
◆ 
T4b: Cancer directly invades the adjacent structures (SI) 
16.2.5.3 Records of tumor metastasis 
(1) Lymph node metastasis: 
 
NX: Number of lymph node metastases is unknown 
N0: No lymph node metastasis 
N1: Lymph node metastasis of 1-2 areas 
N2: Lymph node metastasis of 3-6 areas 
N3: Lymph node metastasis of 7 and more areas 
◆ 
N3a: Lymph node metastasis of 7-15 areas 
◆ 
N3b: Lymph node metastasis of 16 and more areas 
Lymph node numbers are defined as follows: 
No. 
Name 
Definition 
1 
Cardia right 
Lymph nodes around the gastric wall first branch (cardia branch) of 
ascending branches of the left gastric artery and those at the cardia 
sides 
2 
Cardia left 
Lymph nodes at the left side of the cardia and those along the cardia 
branch of the lower left diaphragmatic artery esophagus 
3a 
Lesser 
gastric 
curvature 
(along the left 
gastric artery) 
Lymph nodes at the lesser curvature side along the left gastric artery 
branch, below the cardia branch 
3b 
Lesser 
gastric 
curvature 
(along the right 
gastric artery) 
Lymph nodes at the lesser curvature side along the right gastric 
artery branch, partial left side of the 1st branch in the lesser 
curvature direction 
4sa 
Left side of the 
greater 
gastric 
curvature (short 
gastric artery) 
Lymph nodes along the short gastric artery (excluding the root) 

Study protocol 
51 
 
 
 
4sb 
Left side of the 
greater 
gastric 
curvature 
(along the left 
gastroepiploic 
artery) 
Lymph nodes along the left gastroepiploic artery and the first branch 
of the greater curvature (refer to the definition of No. 10) 
4d 
Right side of 
the 
 greater 
gastric 
curvature 
(along the right 
gastroepiploic 
artery) 
Lymph nodes at the partial left side of the first branch in the greater 
gastric curvature direction along the right gastroepiploic artery 
5 
Superior 
pylorus 
Lymph nodes along the right gastric artery and around the first 
branch in the lesser gastric curvature direction 
6 
Inferior pylorus 
Lymph nodes from the root of the right gastroepiploic artery to the 
first branch in the greater gastric curvature direction and those at the 
junction of the right gastroepiploic veins and superior anterior 
pancreaticoduodenal veins (including the junction portion) 
7 
Left 
gastric 
artery trunk 
Lymph nodes from the root of the left gastric artery to the branch 
portion of the ascending branches 
8a 
Anterior upper 
part 
of 
the 
common 
hepatic artery 
Lymph nodes at the anterior upper part of the common hepatic artery 
(from the branch portion of the splenic artery to the branch portion 
of the gastroduodenal artery) 
8p 
Posterior part of 
the 
common 
hepatic artery 
Lymph nodes at the posterior part of the common hepatic artery 
(from the branch portion of the splenic artery to the branch portion 
of the gastroduodenal artery) 
9 
Surrounding of 
the celiac artery 
Lymph gland that is in the surroundings of the celiac artery or that is 
a part of each root of the left artery of the stomach, common hepatic 
artery and splenic artery as well as that related to the celiac artery 
10 
Splenic hilum 
Lymph gland that is in the surroundings of the celiac artery and 
splenic hilum far away from the end of the pancreas, including the 
first greater gastric curvature in the root of the short gastric artery 
and the left gastroepiploic artery 
11p 
Splenic artery 
proximal 
Lymph gland at the splenic artery proximal (in a location that  
divides the distance between the root of the splenic artery and the 
end of the pancreas into two equal parts, including the proximal 
side) 
11d 
Splenic artery 
distal 
Lymph gland at the splenic artery distal (in a location that divides 
the distance between the root of the splenic artery and the end of the 
pancreas into two equal parts, inclining to the end of the pancreas) 
12a 
Within the 
hepatoduodenal 
Lymph gland that is below a location that divides the height of the 
confluence portions  of  the left and right  hepatic ducts  and the bile 

Study protocol 
52 
 
 
 
ligament (along 
the 
proper hepatic 
artery) 
duct in the upper margin of the pancreas into two equal parts and is 
along the proper hepatic artery (as stated in No. 12a2 of the 
regulations for bile duct carcinoma) 
12b 
Within the 
hepatoduodenal 
ligament (along 
the bile duct) 
Lymph gland that is below a location that divides the height of the 
confluence portions of the left and right hepatic ducts and the bile 
duct in the upper margin of the pancreas into two equal parts and is 
along the proper hepatic artery (as stated in No. 12b2 of the 
regulations for bile duct carcinoma) 
12p 
Within the 
hepatoduodenal 
ligament (along 
the portal vein) 
Lymph gland that is below a location that divides the height of the 
confluence portions of the left and right hepatic ducts and the bile 
duct in the upper margin of the pancreas into two equal parts and is 
along the proper hepatic artery (as stated in No. 12p2 of the 
regulations for bile duct carcinoma) 
13 
Back 
of 
the 
pancreatic 
head 
Lymph gland adjacent to the head of the duodenal papilla at the back 
of the pancreatic head (No. 12b in the surroundings of the 
hepatoduodenal ligament) 
14v 
Along 
the 
superior 
mesenteric vein 
Lymph gland that is in the front of the superior mesenteric vein, with 
the inferior margin of the pancreas on the upper side, the right 
gastroepiploic vein and confluence portion of the superior 
pancreaticoduodenal vein to the right, the left margin of the 
mesenteric vein to the left and the branch of the middle colic vein in 
the lower margin 
14a 
Along 
the 
superior 
mesenteric 
artery 
Lymph gland along the superior mesenteric artery 
15 
Surroundings of 
the 
colon 
middle artery 
Lymph gland that is in the surroundings of the colon middle artery 
16a1 
Surroundings of 
the 
abdominal 
aorta a1 
Lymph gland that is in the surroundings of the aorta gap (4 to 5 cm 
wide in the surroundings of the medial crus of the diaphragm) 
16a2 
Surroundings of 
the 
abdominal 
aorta a2 
Lymph gland that is in the surroundings of the aorta from the upper 
margin of the abdominal artery root to the lower margin of the left 
renal vein 
16b1 
Surroundings of 
the 
abdominal 
aorta b1 
Lymph gland that is in the surroundings of the aorta from the lower 
margin of the left renal vein to the upper margin of the inferior 
mesenteric artery root 
16b2 
Surroundings of 
the 
abdominal aorta 
b2 
Lymph gland that is in the surroundings of the aorta from the upper 
margin of the inferior mesenteric artery root to the branch of aorta 
17 
Front 
of 
the Lymph gland that is in the front of the pancreatic head, next to the 

Study protocol 
53 
 
 
 
pancreatic 
head 
pancreas and under the pancreatic capsule 
18 
Below the 
pancreas 
Lymph gland that is in the lower margin of the pancreas 
19 
Below 
the 
diaphragm 
Lymph gland that is in the cavity of the diaphragm and along the 
lower side of the diaphragmatic artery 
20 
Hiatal part of 
the gullet 
Lymph gland that connects the hiatal part of diaphragm to the gullet 
110 
Beside 
the 
lower gullet 
Lymph gland that departs from the diaphragm and is next to the 
lower gullet 
111 
Above 
the 
diaphragm 
Lymph gland that is in the cavity of the diaphragm and departs from 
the gullet (No. 20 that connects to the diaphragm and gullet) 
112 
Posterior 
mediastinum 
Lymph gland of the posterior mediastinum departed from the gullet 
and its hiatal portion 
 
 
 

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54 
 
 
 
 
 
 
Fig. 4. Lymph node grouping 
(2) Distant metastasis 
 
M0: No distant metastasis outside of the regional lymph nodes 
M1: Distant metastasis outside of the regional lymph nodes 
MX: Presence of distant metastasis is unclear 
Record the specific sites under the M1 condition: peritoneum (PER), liver (HEP), lymph 
node (LYM), skin (SKI), lung (PUL), bone marrow (MAR), bone (OSS), pleura (PLE), brain 
(BRA) and meninges (MEN), intraperitoneal exfoliated cells (CY), and others (OTH). Note: A 
positive examination result for intraperitoneal exfoliated cells is recorded as M1. 
16.2.5.4 Tumor Staging 

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55 
 
 
 
 
16.2.5.5 
Pathologic types and classifications 
16.2.5.5.1 Type 
 
Papillary adenocarcinoma 
Tubular adenocarcinoma 
Mucinous adenocarcinoma 
Signet ring cell carcinoma 
Poorly differentiated carcinoma 
16.2.5.5.2 Grading 
 
GX classification is not possible to assess 
G1 well-differentiated 
G2 moderately differentiated 
G3 poorly differentiated 
G4 undifferentiated 
16.2.5.6 
Evaluation of Radical Level (Degree) 
16.2.5.6.1 Recording the Presence or Absence of Cancer Invasion on the Resection Stump 
(1) Proximal incisional margin (PM: proximal margin) 
 
PM (-): No cancer invasion found on the proximal incisional margin 
PM (+): Cancer invasion found on the proximal incisional margin 
PM X: Unknown cancer invasion on the proximal incisional margin 
(2) Distal incisional margin (DM: distal margin) 
 
DM (-): No cancer invasion found on the distal incisional margin 
DM (+): Cancer invasion found on the distal incisional margin 
DM X: Unknown cancer invasion on the distal incisional margin 

60 
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16.2.5.6.2 Radical Records 
Postoperative residual tumor, denoted with R (residual tumor): R0: curative resection; R1, R2: 
non-curative resection. 
RX: cannot be evaluated 
R0: no residual cancer 
R1: microscopic residual cancer (positive margins, peritoneal lavage cytology positive) 
R2: macroscopic residual cancer