Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer

Fujian Medical University0 sites110 target enrollmentNovember 1, 2016

ConditionsStomach Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stomach Neoplasms
Sponsor: Fujian Medical University
Enrollment: 110
Primary Endpoint: overall postoperative morbidity rates
Status: Enrolling By Invitation
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.

Registry

clinicaltrials.gov

Start Date

November 1, 2016

End Date

November 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.

Professor

Fujian Medical University

Eligibility Criteria

Inclusion Criteria

•Age between 18 to 75 years old
•Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
•Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
•No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
•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

•Pregnant and lactating women
•Suffering from severe mental disorder
•History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
•History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
•Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
•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
•History of continuous systematic administration of corticosteroids within 1 month

Outcomes

Primary Outcomes

overall postoperative morbidity rates

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.

Secondary Outcomes

3-year disease free survival rate(36 months)
Postoperative pain(30 days)
The variation of cholesterol(3, 6, 9 and 12 months)
The results of endoscopy(3 and 12 months)
The variation of body temperature(8 days)
3-year recurrence pattern(36 months)
Time to first ambulation(30 days)
Time to first liquid diet(30 days)
The variation of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
Time to first soft diet(30 days)
The variation of C-reactive protein(Preoperative 3 days and postoperative 1, 3, and 5 days)
3-year overall survival rate(36 months)
Intraoperative morbidity rates(1 day)
Time to first flatus(30 days)
Duration of postoperative hospital stay(30 days)
The variation of weight(3, 6, 9 and 12 months)
The variation of hemoglobin(Preoperative 3 days and postoperative 1, 3, and 5 days)