Prospective Randomized Controlled Trial for Comparison of Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer

Fujian Medical University1 site in 1 country220 target enrollmentJune 1, 2018

ConditionsStomach Neoplasm Robotic Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Stomach Neoplasm
Sponsor: Fujian Medical University
Enrollment: 220
Locations: 1
Primary Endpoint: 3-year disease free survival rate
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer

Detailed Description

Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.

Registry

clinicaltrials.gov

Start Date

June 1, 2018

End Date

November 30, 2024

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fujian Medical University

Responsible Party

Principal Investigator

Chang-Ming Huang, Prof.

Director, Head of gastric surgery, Principal Investigator, Clinical Professor

Fujian Medical University

Eligibility Criteria

Inclusion Criteria

•Age from over 18 to under 75 years
•Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
•The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results.
•Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
•ASA (American Society of Anesthesiology) class I to III
•Written informed consent

Exclusion Criteria

•cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
•Women during pregnancy or breast-feeding
•Severe mental disorder
•History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
•Multiple primary cancer
•History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
•Gastric multiple primary carcinoma
•Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
•History of other malignant disease within the past 5 years
•History of previous neoadjuvant chemotherapy or radiotherapy

Outcomes

Primary Outcomes

3-year disease free survival rate

Time Frame: 36 months

the rate of 3-year disease free survival

Secondary Outcomes

3-year overall survival rate(36 months)
Time to first flatus(30 days)
operation time(1 day)
3-year recurrence pattern(36 months)
Time to first liquid diet(30 days)
intraoperative morbidity rates(1 day)
overall postoperative serious morbidity rates(30 days)
The variation of weight(3, 6, 9 and 12 months)
overall postoperative morbidity rates(30 days)
Time to first ambulation(30 days)
Time to first soft diet(30 days)
Duration of postoperative hospital stay(30 days)
The variation of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
Hospitalization expenses(30 days)