Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer - Full Text View

Sponsored by:	Wakayama Medical University
Information provided by:	Wakayama Medical University
ClinicalTrials.gov Identifier:	NCT00746161

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 III

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer

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
1: Active Comparator Roux-en-Y	Procedure: Reconstruction after total gastrectomy Roux-en-Y
2: Experimental 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

Responsible Party:	Wakayama Medical University ( Second Department of Surgery )
Study ID Numbers:	WMU-GC02
Study First Received:	September 2, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00746161
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

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009