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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Dazhi Xu, PHD, MD
xudzh@shca.org.cn
021-64175590
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 600
Treatments
Experimental: Laparoscopic Total Gastrectomy
Active_comparator: Open Total Gastrectomy
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov