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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014