Clinical trial NCT04795063: Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Official title: Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Robotic Gastrectomy
Keywords: Gastric Cancer
robotic assisted distal gastrectomy
total robotic distal gastrectomy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).

Detailed description: 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 total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.

Eligibility criteria: Inclusion Criteria:

1. Age from over 18 to under 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
6. American Society of Anesthesiology (ASA) class I to III
7. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
5. Gastric multiple primary carcinoma
6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
7. History of other malignant disease within the past 5 years
8. History of previous neoadjuvant chemotherapy or radiotherapy
9. History of unstable angina or myocardial infarction within the past 6 months
10. History of cerebrovascular accident within the past 6 months
11. History of continuous systematic administration of corticosteroids within 1 month
12. Requirement of simultaneous surgery for other disease
13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
14. Forced expiratory volume in 1 second (FEV1)\<50% of the predicted values

Primary outcomes:
measure: Morbidity rates
timeFrame: 30 days
Secondary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: intraoperative morbidity rates
timeFrame: 1 day
measure: overall postoperative serious morbidity rates
timeFrame: 30 days
measure: Total Number of Retrieved Lymph Nodes
timeFrame: 1 day
measure: postoperative recovery course
timeFrame: 30 days
measure: postoperative nutritional status
timeFrame: 3, 6, 9 and 12 months
measure: inflammatory immune response
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: Time of digestive tract reconstruction
timeFrame: 1 day
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-ming Huang, MD
role: STUDY_CHAIR
References: