the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

Study Overview
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Brief Summary
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To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .

Detailed Description
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In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.

Official Title
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A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer

Conditions
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Gastric Cancer, Robotic Gastrectomy

Intervention / Treatment
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* Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy
* Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy. 3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection. 5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent Exclusion Criteria: Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging ) Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy(except for ESD/EMR for gastric cancer ) Enlarged or bulky regional lymph node over 3 cm by preoperative imaging History of other malignant disease within the past five years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy) Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1 (forced expiratory volume in one second)<50% of predicted values

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic radical total gastrectomy with D2 lymphadenectomy<br>After exploration and randomization, patients received robotic radical total gastrectomy with D2 lymphadenectomy | Procedure: Robotic radical total gastrectomy with D2 lymphadenectomy<br>* Most surgical procedures are performed using the robot system.<br>|
| Active Comparator: Laparoscopic radical total gastrectomy with D2 lymphadenectomy<br>After exploration and randomization, patients received laparoscopic radical total gastrectomy with D2 lymphadenectomy | Procedure: Laparoscopic radical total gastrectomy with D2 lymphadenectomy<br>* Without the robot system, Most surgical procedures are performed using laparoscopic equipment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rates | This is for the early postoperative complication, which defined as the event observed within 30 days after surgery. | 30 days | 
| 3-year overall survival rate | 3-year overall survival rate | 36 months | 
| 3-year recurrence pattern | Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. | 36 months | 
| intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 day | 
| overall postoperative serious morbidity rates | Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher | 30 days | 
| Total Number of Retrieved Lymph Nodes | Total Number of Retrieved Lymph Nodes | 1 day | 
| postoperative recovery course | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days | 
| postoperative nutritional status | The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. | 3, 6, 9 and 12 months | 
| inflammatory immune response | The variation of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response | Preoperative 3 days and postoperative 1, 3, and 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic radical total gastrectomy, Gastric Cancer, laparoscopic radical total gastrectomy