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Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total Gastrectomy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic Total Gastrectomy

Open Total Gastrectomy

Arm Description

Outcomes

Primary Outcome Measures

3 year-DFS
3 year-disease free survival

Secondary Outcome Measures

3 year-OS
3 year-overall survival
morbidity and mortality rates
morbidity and mortality within 30 days following surgeries

Full Information

First Posted
September 8, 2022
Last Updated
September 8, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05537129
Brief Title
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, Laparoscopic Total Gastrectomy, Open Total Gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Total Gastrectomy
Arm Type
Experimental
Arm Title
Open Total Gastrectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Total Gastrectomy
Intervention Description
The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.
Primary Outcome Measure Information:
Title
3 year-DFS
Description
3 year-disease free survival
Time Frame
3 year
Secondary Outcome Measure Information:
Title
3 year-OS
Description
3 year-overall survival
Time Frame
3 year
Title
morbidity and mortality rates
Description
morbidity and mortality within 30 days following surgeries
Time Frame
30 days following surgeries

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dazhi Xu, PHD, MD
Phone
021-64175590
Email
xudzh@shca.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dazhi Xu, PHD,MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dazhi Xu, PHD，MD
Phone
021-64175590
Email
xudzh@shca.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

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