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

Wakayama Medical University

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Procedure: Reconstruction after total gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00746161

WMU-GC02

Details and patient eligibility

About

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

Full description

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

Enrollment: 44 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

1

Active Comparator group

Description:

Roux-en-Y

Treatment:

Procedure: Reconstruction after total gastrectomy

Procedure: Reconstruction after total gastrectomy

2

Experimental group

Description:

double tract reconstruction

Treatment:

Procedure: Reconstruction after total gastrectomy

Procedure: Reconstruction after total gastrectomy