Evidence map›Paper›PMID 41189489›Full record

ArticleBJS open2025

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.

Wen-Quan Wang, Yao-Lin Xu, Lin-Hui Tang, Jun-Yi He, Yu Li, Fei Liang, Yue-Ming Zhang, Wei Gan, Hua-Xiang Xu, Lei Zhang and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BJS open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06322680 (The Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06322680 narecruitingnot on this map

The Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy: A Multi-center Prospective Randomized Controlled Phase Clinical Trial

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2024 to 2027Enrolled322ConditionsPancreaticoduodenectomyArmsMain pancreatic duct and biliary duct external drainage, Main pancreatic duct and biliary duct internal drainage
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Wen-Quan WangDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Yao-Lin XuDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Lin-Hui TangDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Jun-Yi HeDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Yu LiDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Fei LiangDepartment of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Yue-Ming ZhangDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Wei GanDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Hua-Xiang XuDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Lei ZhangDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Wen-Chuan WuDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Chen-Ye ShiDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Yun JinDepartment of Hepatobiliary Surgery, First People's Hospital of Yunnan Province, Kunming 650032, China.
Chong-Yi JiangDepartment of Hepato-Biliary-Pancreatic Surgery, Huadong Hospital Affiliated to Fudan University, Shanghai 200040, China.
Zheng WangDepartment of Hepatobiliary Surgery, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
Min HeDepartment of Biliary-Pancreatic Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital, Shanghai 200001, China.
Xu-An WangDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Yu-Dong QiuDepartment of General Surgery, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing 210008, China.
Liang LiuDepartment of Pancreatic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.

Funding

Beijing Xisike Clinical Oncology Research Foundation 202305AF150148Beijing Xisike Clinical Oncology Research Foundation Y-2022METAZQN-0003Beijing Xisike Clinical Oncology Research Foundation Y-Gilead2024-PT-0002Beijing Xisike Clinical Oncology Research Foundation Y-HR2022MS-0251Beijing Xisike Clinical Oncology Research Foundation Y-HR2022QN-0085Beijing Xisike Clinical Oncology Research Foundation ZSLCYJ202329National Natural Science Foundation of China 82272929National Natural Science Foundation of China 82273382National Natural Science Foundation of China 82303443National Natural Science Foundation of China 82473459Program of Shanghai Academic/Technology Research Leader 201940019Program of Shanghai Academic/Technology Research Leader 20244Y0023Program of Shanghai Academic/Technology Research Leader 23XD1400600Program of Shanghai Academic/Technology Research Leader 24PJD012Program of Shanghai Academic/Technology Research Leader 24SF1900300Program of Shanghai Academic/Technology Research Leader SACA-CY24B09Zhongshan Hospital 2023ZSCX21
6 · The paper itself

Abstract

backgroundAccording 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.

methodsThis 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.

conclusionThis 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).

Indexed as

Common Bile DuctDrainagePancreatic DuctsPancreatic FistulaPancreaticoduodenectomyPostoperative ComplicationsEquivalence Trials as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as Topiccomplicationsinternal drainagePOPFwirsungianus

Identifiers

PMID41189489
PMCPMC12587152

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.