Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Study Overview
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Brief Summary
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This study is a prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial comparing robotic-assisted total gastrectomy with D2 lymph nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.

Detailed Description
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Since Kitano firstly reported laparoscopy-assisted distal gastrectomy in 1994, the number of patients undergoing the laparoscopic procedure has gradually increased. The latest Japanese gastric cancer treatment guideline recommends laparoscopic gastrectomy (LG) as an optional treatment for cStage Ⅰ gastric cancer (GC). Based on the experience of early GC, most experienced surgeons have applied the laparoscopic procedure in patients with locally advanced gastric cancer (AGC) especially in east world like China, Japan and Korea. Though applying laparoscopic-assisted total gastrectomy (LATG) is much more difficulty than that of distal gastrectomy (DG), there are a mount of centers reported their experiences of this procedure. A meta-analysis including seventeen studies of 2313 patients (955 in LATG and 1358 in open total gastrectomy) demonstrated that LATG can have less blood loss, fewer analgesic uses, earlier passage of flatus, quicker resumption of oral intake, earlier hospital discharge, and reduced postoperative morbidity. However, the number of harvested lymph nodes, proximal resection margin, hospital mortality, 5-year OS and DFS were similar in both groups. According to the existing reports, LATG is technically safety and feasibility. To overcome the limitations of laparoscopic surgery, robot systems have been introduced to treat GC providing technical advantages since Hashizume firstly reported. Yoon and Son respectively compared robot-assisted total gastrectomy (RATG) with LATG, they drew a common conclusion that the number of dissected lymph nodes and postoperative complications were similar in both groups. But Son found that the mean numbers of retrieved LNs along the splenic artery from RATG was higher than LATG (2.3 vs. 1.0, p = 0.013), as was also the case at the splenic hilum and artery (3.6 vs.1.9, p = 0.014). Regretfully, most of their reported cases were early gastric cancer (EGC). Other literatures reported AGC patients under RATG or LATG together with distal gastrectomy (DG), we haven't found any literature compare RATG with LATG alone for AGC retrospectively. Since most literatures are EGC patients and retrospectively researches, we can't insist that patients with AGC may benefit under RATG. Therefore, we launch this prospective, single-center, non-randomized, controlled, non-blind, and non-inferiority observation trial comparing RATG for locally advanced gastric cancer patients with LATG.In the process of research,it will be divided into two groups according to the willing of patients or their legal representatives who choose one of the two procedures(RATG or LATG) to cure GC.The primary objective of this study is to assess whether RATG is comparable to laparoscopic approach in terms of overall postoperative morbidity rates. The secondary research objectives are to compare robotic with laparoscopic approach in terms of surgical outcomes, postoperative recovery courses.

Official Title
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Safety and Feasibility Between Robotic and Laparoscopic Total Gastrectomy With D2 Lymphadenectomy for Locally Advanced Gastric Cancer：A Prospective Cohort Study

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Robotic-assisted Total Gastrectomy
* Procedure: Laparoscopic-assisted Total Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven gastric adenocarcinoma; Age: older than 18 years old, younger than 80 years old; Tumor located in the upper third of the stomach or esophagogastric junction or other location, and is possible to be curatively resected by total gastrectomy; Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition; American Society of Anesthesiology (ASA) score of class I to III; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Patients who freely give informed consent to participate in the clinical study; Exclusion Criteria: Early gastric cancer; Age: younger than 18 years old, older than 80 years old; Total gastrectomy with D2 lymphadenectomy was not required; Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; Emergency surgery for gastric cancer-related complications (bleeding or complete obstruction or perforation); Previous upper abdominal surgery (except laparoscopic cholecystectomy); Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer; Unstable angina or myocardial infarction within the past 6 months; Cerebrovascular accident within the past 6 months; American Society of Anesthesiology (ASA) score of class more than III; Severe respiratory disease (FEV1< 50%); Continuous systemic steroid therapy within 1 month before the study; Pregnant or breast-feeding women;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic surgery<br>Robotic-assisted Total Gastrectomy with D2 Lymphadenectomy | Procedure: Robotic-assisted Total Gastrectomy<br>* Robotic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose robotic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.<br>|
| Compared: Laparoscopic surgery<br>Laparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy | Procedure: Laparoscopic-assisted Total Gastrectomy<br>* Laparoscopic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose laparoscopic-assisted total gastrectomy and exclusing T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall postoperative morbidity and mortality | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of operation | The total time of operation | 1 day | 
| Estimated blood loss | Blood loss during intraoperative including the volume of negative pressure drainage bottle and the increasing weight of gauzes （ml） | 1 day | 
| Blood transfusion | Blood transfusion during operation | 1 day | 
| Length of proximal and distal cutting margin | Length of proximal and distal cutting margin of the specimen | 1 day | 
| Number of retrieved lymph nodes | Total number of harvested perigastric lymph node | 7 days | 
| Time to flatus | Time of anus exsufflation | 30 days | 
| Time to first ambulation | Time to walking about | 30 days | 
| Time to liquid diet | Time to liquid diet | 30 days | 
| Time to soft diet | Time to soft diet | 30 days | 
| Duration of postoperative hospital stay | Time from operation to hospital discharge | 30 days | 
| cost | All costs of hospitalization | 30days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic, Robotic, Total Gastrectomy, AGC