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

October 16, 2021 updated by: Yan Shi, Southwest Hospital, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery,Southwest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with gastric cancer who need to received total gastrectomy with D2 lymphadenectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental: Robotic surgery
Robotic-assisted Total Gastrectomy with D2 Lymphadenectomy
Procedure: Robotic-assisted Total Gastrectomy
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.
Compared: Laparoscopic surgery
Laparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy
Procedure: Laparoscopic-assisted Total Gastrectomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall postoperative morbidity and mortality
Time Frame: 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.
30 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year Overall survival rate
Time Frame: 3 years
3-year Overall survival rate
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Hospital, China

Investigators

  • Study Chair: Peiwu Yu, M.D., Southwest Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2018

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 14, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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