Trial Information

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

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.