Prospective randomized controlled trial of omental roll-up technique on pancreatojejunostomy anastomosis for reducing perioperative complication in patients undergoing pancreatoduodenectomy

Background: Wrapping pancreatojejunal anastomosis with omentum to prevent postoperative pancreatic fistula (POPF) has only been reported in non-randomized, controlled trials. Therefore, this study aimed to conduct a randomized, controlled trial to compare outcomes between omental roll-up and non-omental roll-up in pancreatojejunal anastomosis. Methods: This single-center, randomized, two-arm trail (Clinical Trials Register: NCT03083938) was conducted between February 2017 and February 2019. We studied 34 patients in the omental roll-up group and 34 patients in the non-omental roll-up group. The primary endpoint was the incidence of clinically relevant POPF. Thirty-day mortality and morbidity were recorded. Results: Patients’ demographic data were not significantly different between the two groups, except for histological diagnosis, with a significantly higher incidence of pancreatic cancer in the omental roll-up group (n = 15, 44.1%) than in the non-omental roll-up group (n = 9, 26.4%) (P = 0.042). There was one death in the non-omental roll-up group due to myocardial infarction. The incidence of POPF was not different between the omental roll-up group (n = 5, 14.7%) and non-omental roll-up group (n = 7, 20.6%) (P = 0.525). No differences were found in postoperative hemorrhage after pancreatectomy, delayed gastric emptying, and chyle leakage between the groups. Conclusion: This study shows that omental roll-up does not decrease the incidence of POPF after pancreatoduodenectomy.