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

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Laparoscopic-assisted Total Gastrectomy; Procedure: Robotic-assisted Total Gastrectomy

• Registration Number: NCT03500471
• Lead Sponsor: Southwest Hospital, China

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-04-14
• Study Start: 2018-04-16
• Study First Posted: 2018-04-18
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-16
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Pathologically proven gastric adenocarcinoma;
2. Age: older than 18 years old, younger than 80 years old;
3. 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;
4. Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition;
5. American Society of Anesthesiology (ASA) score of class I to III;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
7. Patients who freely give informed consent to participate in the clinical study;

Exclusion Criteria

1. Early gastric cancer;
2. Age: younger than 18 years old, older than 80 years old;
3. Total gastrectomy with D2 lymphadenectomy was not required;
4. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
5. Emergency surgery for gastric cancer-related complications (bleeding or complete obstruction or perforation);
6. Previous upper abdominal surgery (except laparoscopic cholecystectomy);
7. Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer;
8. Unstable angina or myocardial infarction within the past 6 months;
9. Cerebrovascular accident within the past 6 months;
10. American Society of Anesthesiology (ASA) score of class more than III;
11. Severe respiratory disease (FEV1< 50%);
12. Continuous systemic steroid therapy within 1 month before the study;
13. Pregnant or breast-feeding women;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Compared: Laparoscopic surgery	Laparoscopic-assisted Total Gastrectomy	Laparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy
Experimental: Robotic surgery	Robotic-assisted Total Gastrectomy	Robotic-assisted Total Gastrectomy with D2 Lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Overall postoperative morbidity and mortality	30 days	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery,Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China