Randomized Controlled Trials on Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer

Fujian Medical University1 site in 1 country300 target enrollmentSeptember 25, 2017

ConditionsStomach Neoplasm Robotic Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stomach Neoplasm
Sponsor: Fujian Medical University
Enrollment: 300
Locations: 1
Primary Endpoint: 3-year disease free survival rate
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to explore the clinical outcomes of the robotic distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.

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 distal gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic distal gastrectomy in the treatment of gastric adenocarcinoma （cT1-4a, N-/+, M0）.

Registry

clinicaltrials.gov

Start Date

September 25, 2017

End Date

January 13, 2023

Last Updated

2 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
•cT1-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
•expected to perform distal gastrectomy with D1+/D2 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

•Women during pregnancy or breast-feeding
•Severe mental disorder
•History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
•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
•History of unstable angina or myocardial infarction within the past 6 months
•History of cerebrovascular accident within the past 6 months

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)
3-year recurrence pattern(36 months)
overall postoperative morbidity rates(30 days)
intraoperative morbidity rates(1 day)
overall postoperative serious morbidity rates(30 days)
number of retrieved lymph nodes(1 days)
Time to first flatus(30 days)
Time to first soft diet(30 days)
Duration of postoperative hospital stay(30 days)
The variation of white blood cell count(Preoperative 7 days and postoperative 1 and 5 days)
the noncompliance rate of lymphadenectomy(1 days)
Time to first ambulation(30 days)
Time to first liquid diet(30 days)
The variation of weight(3, 6, 9 and 12 months)
The variation of cholesterol(3, 6, 9 and 12 months)
The variation of album(3, 6, 9 and 12 months)
The variation of hemoglobin(Preoperative 7 days and postoperative 1 and 5 days)
Hospitalization expenses(30 days)
operation time(1 days)