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


Phase 3
N/A
80 Years
Not Enrolling
Both
Gastric Cancer

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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

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