Abstract
BACKGROUND: According to a retrospective study at Zhongshan Hospital, external drainage of the main pancreatic duct (MPD) and common bile duct (CBD) is potentially superior over internal drainage. As yet there is no consensus regarding the optimal drainage strategy, and previous studies have not adequately addressed risk stratification for postoperative pancreatic fistula (POPF). The aim of this study is to determine the clinical advantage of external drainage of the MPD and CBD over internal drainage during pancreatoduodenectomy. METHODS: This multicentre randomized clinical superiority study is designed to compare the effects of external and internal drainage of the MPD and CBD on the incidence of postoperative complications for patients at intermediate or high risk of POPF. In all, 322 eligible patients will be recruited across six pancreatic centres and randomly assigned 1 : 1 to either an external or internal drainage group. The primary outcome is the incidence of clinically relevant POPF (Grade B/C) within 90 days after surgery. The anticipated duration of enrolment is 1 year, along with a minimum follow-up period of 2 years, with follow-up visits every 3 months. CONCLUSION: This trial will provide evidence for the efficacy of simultaneous external drainage of the MPD and CBD in the management of pancreatoduodenectomy, optimizing drainage strategies for pancreatoduodenectomy and facilitating the adoption of advanced drainage technologies. Registration number: NCT06322680 (http://www.clinicaltrials.gov); ChiCTR2400086321 (https://www.chictr.org.cn).