A Trial of Reconstruction After Distal Gastrectomy for Gastric Cancer

Wakayama Medical University

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Procedure: Roux-en Y reconstruction; Procedure: Billroth-I reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01065688

WMU-GC03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Roux-en Y

Active Comparator group

Description:

Roux-en Y reconstruction after distal gastrectomy

Treatment:

Procedure: Roux-en Y reconstruction

Billroth-I

Experimental group

Description:

Billroth-I reconstruction after distal gastrectomy

Treatment:

Procedure: Billroth-I reconstruction