Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

NCT05537129 | Recruiting

• 1 other identifier: LOTGGC
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy

Outcome Measures

Primary Outcomes (1)

• 3 year-DFS

  3 year-disease free survival

  3 year

Secondary Outcomes (2)

• 3 year-OS

  3 year

• morbidity and mortality rates

  30 days following surgeries

Study Arms (2)

Laparoscopic Total Gastrectomy

EXPERIMENTAL

Procedure: Total Gastrectomy

Open Total Gastrectomy

ACTIVE COMPARATOR

Procedure: Total Gastrectomy

Interventions

Total Gastrectomy PROCEDURE

The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.

Laparoscopic Total Gastrectomy; Open Total Gastrectomy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• currently participating or participated in other clinical trials in the last 6 months

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Dazhi Xu, PHD,MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dazhi Xu, PHD, MD

CONTACT

021-64175590; xudzh@shca.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD,MD

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)