Trial Information
A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer
Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT
reconstruction after total gastrectomy.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The %body weight ratio
Outcome Time Frame:
12 months after operation
Safety Issue:
No
Principal Investigator
Makoto Iwahashi
Investigator Role:
Principal Investigator
Investigator Affiliation:
Second Department of Surgery, Wakayama Medical University
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
WMU-GC02
NCT ID:
NCT00746161
Start Date:
April 2002
Completion Date:
April 2008
Related Keywords:
- Gastric Cancer
- total gastrectomy
- double tract reconstruction
- gastric cancer
- Total gastrectomy in patients with gastric cancer
- Stomach Neoplasms