A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

A Prospective Randomized Controlled Trial Comparing Billroth-I Reconstruction With Roux-en Y Reconstruction After Distal Gastrectomy for Gastric Cancer

Sponsors

Lead Sponsor: Wakayama Medical University

Source 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.

Overall Status Completed
Start Date 2009-01-01
Completion Date 2013-11-01
Primary Completion Date 2013-09-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
the postoperative quality of life (QOL) 3 years after operation
Secondary Outcome
Measure Time Frame
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
Enrollment 120
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Roux-en Y reconstruction

Description: surgical procedure

Arm Group Label: Roux-en Y

Intervention Type: Procedure

Intervention Name: Billroth-I reconstruction

Description: surgical procedure

Arm Group Label: Billroth-I

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Masaki Nakamura, MD Principal Investigator Second Department of Surgery, Wakayama Medical University
Location
Facility: Second Department of Surgery, Wakayama Medical University
Location Countries

Japan

Verification Date

2018-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Wakayama Medical University

Investigator Full Name: Hiroki Yamaue

Investigator Title: Second Department of Surgery, Wakayama Medical University

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Roux-en Y

Type: Active Comparator

Description: Roux-en Y reconstruction after distal gastrectomy

Label: Billroth-I

Type: Experimental

Description: Billroth-I reconstruction after distal gastrectomy

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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