Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Total Gastrectomy

Detailed Description

Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dazhi Xu, PHD, MD; Phone Number: 021-64175590; Email: xudzh@shca.org.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Dazhi Xu, PHD，MD; Phone Number: 021-64175590; Email: xudzh@shca.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
2. age between 20 and 80 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. 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)
5. 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
6. written informed consent
7. without preoperative chemotherapy and radiotherapy

Exclusion Criteria:

1. clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
2. history of chemotherapy, radiotherapy, immunotherapy or target therapy
3. perigastric lymphnode≥3cm
4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
5. multiple primary tumors
6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
7. patients need emergency operation with complication of gastric cancer
8. adhesion due to the previous intraabdominal surgery
9. need for combined organ resection due to aggression of gastric cancer of other disease,
10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
11. currently participating or participated in other clinical trials in the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic Total Gastrectomy	Procedure: Total Gastrectomy; The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.
Active Comparator: Open Total Gastrectomy	Procedure: Total Gastrectomy; The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 year-DFS	3 year-disease free survival	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 year-OS	3 year-overall survival	3 year
morbidity and mortality rates	morbidity and mortality within 30 days following surgeries	30 days following surgeries

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Dazhi Xu, PHD,MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: LOTGGC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No