Randomized controlled trial comparing Billroth-I and Roux-en-Y reconstruction in distal gastrectomy for gastric cancer.

Abstract

65 Background: In distal subtotal gastrectomy for gastric cancer, Billroth-I (B-I) reconstruction has been performed predominantly in Japan, while increasing number of surgeons chose Roux-en-Y (R-Y) reconstruction recently. To evaluate the safety and superiority of R-Y we conducted a multi-institutional prospective randomized controlled trial. Methods: Gastric cancer patients who underwent distal gastrectomy were randomized to B-I or R-Y intraoperatively. The primary endpoint was the ratio of body weight loss 1 year after surgery, the secondary endpoints were the incidence of delayed gastric emptying (DGE) and postoperative morbidity. Results: Between Aug 2005 and Dec 2008, a total of 332 patients were enrolled and 163 patients were assigned to B-I and 169 patients to R- Y. The patient's characteristics were well balanced between the two groups. The operation time was significantly longer in R-Y than B-I (median 180 min in B-I vs 214 min in R-Y, p < 0.0001). The postoperative morbidity was 14 patients (8.6%) in B-I and 23 (13.6%) in R-Y (p = 0.14), the incidence of DGE was 7 (4.3%) in B-I vs 16 (9.5%) in R-Y (p = 0.06), and the hospital stay after surgery was 14.1days in B-I vs 16.4 days in R-Y (p = 0.02). There was no hospital death in the two groups. The body weight loss at 1 year after surgery compared to preoperation was -5.4kg (-9.1%) in B-I vs -6.2kg (-9.8%) in R-Y (p = 0.11). Conclusions: The advantage of R- Y reconstruction compared to B-I was not proved in terms of postoperative morbidity either the body weight loss 1 year after surgery. No significant financial relationships to disclose.