Impact of external drainage of the main pancreatic duct and common bile duct on
postoperative pancreatic fistula following pancreatoduodenectomy: protocol for a
multicentre randomized clinical trial
#MMPMID41189489
Wang WQ
; Xu YL
; Tang LH
; He JY
; Li Y
; Liang F
; Zhang YM
; Gan W
; Xu HX
; Zhang L
; Wu WC
; Shi CY
; Jin Y
; Jiang CY
; Wang Z
; He M
; Wang XA
; Qiu YD
; Liu L
BJS Open
2025[Oct]; 9
(6
): ? PMID41189489
show ga
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).
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