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

This study has been completed.
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00746161
First received: September 2, 2008
Last updated: September 3, 2008
Last verified: September 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Gastric Cancer
 Procedure: Reconstruction after total gastrectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • The %body weight ratio [ Time Frame: 12 months after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • preoperative complication, PNI and QOL score [ Time Frame: within one month, and 3 and 12months after operation ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: April 2002
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Roux-en-Y
 Procedure: Reconstruction after total gastrectomy
Roux-en-Y
Experimental: 2
double tract reconstruction
 Procedure: Reconstruction after total gastrectomy
double tract reconstruction

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746161

Locations
Japan
Second Department of Surgery, Wakayama Medical University
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University
Investigators
Principal Investigator: Makoto Iwahashi Second Department of Surgery, Wakayama Medical University
  More Information

No publications provided by Wakayama Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Second Department of Surgery, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT00746161     History of Changes
Other Study ID Numbers: WMU-GC02
Study First Received: September 2, 2008
Last Updated: September 3, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Wakayama Medical University:
total gastrectomy
double tract reconstruction
gastric cancer
Total gastrectomy in patients with gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 21, 2013