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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01065688

Enrollment

120

Registered

2010-02-09

Start date

2009-01-31

Completion date

2013-11-30

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

distal gastrectomy, Billroth-I reconstruction, gastric cancer, QOL

Brief summary

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.

Interventions

PROCEDURERoux-en Y reconstruction

surgical procedure

PROCEDUREBillroth-I reconstruction

surgical procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the postoperative quality of life (QOL)	3 years after operation

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026