Perioperative outcomes after billroth II versus Roux-en-Y reconstruction after radical distal gastrectomy for cancer-a multi-centre randomized controlled trial

Background: Surgery is the mainstay of treatment for resectable gastric cancer. However, the method of reconstruction after distal subtotal gastrectomy (DG) is still a matter of debate. Both Billroth II (B-II) and Roux-en-Y (R-Y) remain accepted as standard of care. Methods: This is a prospective multi-center randomized controlled trial (RCT). Patients who underwent an open or laparoscopic radical DG with curative intent for gastric cancer were randomized into either B-II or R-Y reconstruction. In this study, B-II reconstruction was performed without an additional Braun anastomosis, and the creation of the R-Y jejuno-jejunostomy was done at 40cm of the Roux limb. We measured nutritional status, gastrointestinal (GI) symptoms and quality of life up to 2 years after surgery. The primary endpoint was GI symptoms score 1 year after surgery. This is a report on the feasibility and peri-operative outcomes of the study. Results: From October 2008 to October 2014, 162 patients who underwent DG were randomly allocated to B-II (n=81) and R-Y (n=81) groups. A significant difference was noted in the operative time taken for B-II (247.3 ± 56.7min) compared to R-Y (270.3 ± 58.7min, p=0.012). The B-II and R-Y groups had a morbidity rate of 28.4% and 33.8% respectively (p=0.50) and mortality rate of 1.2% and 2.5% respectively (p=0.62). There were no significant differences in terms of median duration of hospital stay (B-II 9 days, IQR 8-12; R-Y 8 day, IQR 7-12; p=0.20) and median time to resume solid food (BII 5 days, IQR 4-6; R-Y 5 days, IQR 4-6; p=0.36). Conclusion: This is the first multi-center international RCT on gastric cancer surgery in our region. Our early post-operative outcome data shows that both procedures were safe with no significant differences between B-II and R-Y.We await the outcome of our primary endpoint to compare the 2 reconstruction methods.