Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer

September 3, 2008 updated by: Wakayama Medical University

A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer

The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Wakayama, Japan, 641-8510
        • Second Department of Surgery, Wakayama Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
  • Age 80 years or younger
  • No distant metastasis

Exclusion Criteria:

  • Carcinoma in the remnant stomach
  • Stage intravenous (IV)
  • History of laparotomy
  • History of serious heart disease
  • Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
  • Absence of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Roux-en-Y
Procedure: Reconstruction after total gastrectomy
Roux-en-Y
Procedure: Reconstruction after total gastrectomy
double tract reconstruction
EXPERIMENTAL: 2
double tract reconstruction
Procedure: Reconstruction after total gastrectomy
Roux-en-Y
Procedure: Reconstruction after total gastrectomy
double tract reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The %body weight ratio
Time Frame: 12 months after operation
12 months after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
preoperative complication, PNI and QOL score
Time Frame: within one month, and 3 and 12months after operation
within one month, and 3 and 12months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wakayama Medical University

Investigators

  • Principal Investigator: Makoto Iwahashi, Second Department of Surgery, Wakayama Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (ESTIMATE)

September 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2008

Last Update Submitted That Met QC Criteria

September 3, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMU-GC02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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