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.