A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Roux-en Y reconstruction; Procedure: Billroth-I reconstruction

• Registration Number: NCT01065688
• Lead Sponsor: Wakayama Medical University

Brief Summary

The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer.

Detailed Description

The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer. There is no prospective randomized study of the two operative procedures focusing on postoperative QOL. The investigators conducted a prospective randomized trial on 120 patients who underwent distal gastrectomy comparing Billroth-I reconstruction and Roux-en Y reconstruction.

The primary endpoint was the postoperative QOL. The secondary endpoints were the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis. Patients were recruited into this study before surgery, on the basis of whether distal gastrectomy was anticipated at Wakayama Medical University Hospital(WMUH) for gastric cancer, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients with history of other organ malignancies, 3) patients who were diagnosed inadequacy for this study by a physician, and 4) patients without an informed consent.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-06
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Histologically confirmed adenocarcinoma of stomach
• Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
• Tumor located in the antrum or the angle or the lower body of stomach
• Appropriate informed consent was obtained.

Exclusion Criteria

• Patients with severe complications which were possible to prolong hospital stay
• Patients with history of other organ malignancies
• Patients who were diagnosed inadequacy for this study by a physician
• Patients without an informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roux-en Y	Roux-en Y reconstruction	Roux-en Y reconstruction after distal gastrectomy
Billroth-I	Billroth-I reconstruction	Billroth-I reconstruction after distal gastrectomy

Primary Outcome Measures

Name	Time	Method
the postoperative quality of life (QOL)	3 years after operation

Secondary Outcome Measures

Name	Time	Method
the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis	1, 3 and 5 years after operation

Trial Locations

Locations (1)

Second Department of Surgery, Wakayama Medical University; 🇯🇵 Wakayama, Japan