A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer

Fudan University1 site in 1 country600 target enrollmentOctober 1, 2022

ConditionsGastric Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastric Cancer
Sponsor: Fudan University
Enrollment: 600
Locations: 1
Primary Endpoint: 3 year-DFS
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.

Detailed Description

Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

October 1, 2027

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Dazhi Xu

PHD,MD

Fudan University

Eligibility Criteria

Inclusion Criteria

•histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
•age between 20 and 80 years old
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
•scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
•written informed consent
•without preoperative chemotherapy and radiotherapy

Exclusion Criteria

•clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
•history of chemotherapy, radiotherapy, immunotherapy or target therapy
•perigastric lymphnode≥3cm
•received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
•multiple primary tumors
•suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
•patients need emergency operation with complication of gastric cancer
•adhesion due to the previous intraabdominal surgery
•need for combined organ resection due to aggression of gastric cancer of other disease,
•vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)