Evidence map›Paper›PMID 39389431›Full record

Trial reportGastrointestinal endoscopy2025

Impact of difficult biliary cannulation on post-ERCP pancreatitis: secondary analysis of the stent versus indomethacin trial dataset.

Samuel Han, Jingwen Zhang, Valerie Durkalski-Mauldin, Lydia D Foster, Jose Serrano, Gregory A Coté, Ji Young Bang, Shyam Varadarajulu, Vikesh K Singh, Mouen Khashab and 33 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gastrointestinal endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07117318 (Rectal Non-steroid Anti-inflammatory Drugs With or Without Prophylactic Pancreatic Duct Stent for Prevention of Post-ERCP Pancreatitis), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–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.

NCT07117318 narecruitingnot on this map

Rectal Non-steroid Anti-inflammatory Drugs With or Without Prophylactic Pancreatic Duct Stent for Prevention of Post-ERCP Pancreatitis: a Multicenter, Randomized, Non-inferiority Trial

TypeinterventionalSponsorAir Force Military Medical University, ChinaRan2025 to 2028Enrolled1,278ConditionsPost-ERCP Acute Pancreatitis, Non-steroid Anti-inflammatory Drugs, Pancreatic Duct Stent PlacementArmsNSAIDs, NSAIDs plus PDS
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
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  7. Review
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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

43 authors.

Samuel HanDivision of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Jingwen ZhangData Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Valerie Durkalski-MauldinData Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Lydia D FosterData Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Jose SerranoNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Gregory A CotéDivision of Gastroenterology & Hepatology, Oregon Health & Science University, Portland, Oregon, USA.
Ji Young BangOrlando Health Digestive Health Institute, Orlando Health, Orlando, Florida, USA.
Shyam VaradarajuluOrlando Health Digestive Health Institute, Orlando Health, Orlando, Florida, USA.
Vikesh K SinghDivision of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Mouen KhashabDivision of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Richard S KwonDivision of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.
James M ScheimanDivision of Gastroenterology, University of Michigan Medical Center, Ann Arbor, Michigan, USA.
Field F WillinghamDivision of Digestive Diseases, Emory University School of Medicine, Atlanta, Georgia, USA.
Steven A KeilinDivision of Digestive Diseases, Emory University School of Medicine, Atlanta, Georgia, USA.
J Royce GroceDivision of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Peter J LeeDivision of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Somashekar G KrishnaDivision of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Amitabh ChakDivision of Gastroenterology, University Hospitals Case Medical Center, Cleveland, Ohio, USA.
Adam SlivkaDivision of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Daniel MulladyDivision of Gastroenterology, Washington University School of Medicine, St Louis, Missouri, USA.
Vladimir KushnirDivision of Gastroenterology, Washington University School of Medicine, St Louis, Missouri, USA.
James BuxbaumDivision of Gastroenterology, Department of Medicine, University of Southern California, Los Angeles, CA, USA.
Rajesh KeswaniDivision of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Timothy B GardnerSection of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Health, Lebanon, New Hampshire, USA.
Sachin WaniDivision of Gastroenterology & Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Steven A EdmundowiczDivision of Gastroenterology & Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Raj J ShahDivision of Gastroenterology & Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Nauzer ForbesDivision of Gastroenterology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
Amit RastogiDivision of Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, Kansas, USA.
Andrew RossDivision of Gastroenterology, Virginia Mason Medical Center, Seattle, Washington, USA.
Joanna LawDivision of Gastroenterology, Virginia Mason Medical Center, Seattle, Washington, USA.
Patrick YachimskiDivision of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Yen-I ChenDivision of Gastroenterology, McGill University, Montreal, Quebec, Canada.
Alan BarkunDivision of Gastroenterology, McGill University, Montreal, Quebec, Canada.
Zachary L SmithDivision of Gastroenterology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Bret T PetersenDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Andrew Y WangDivision of Gastroenterology and Hepatology, University of Virginia, Charlottesville, Virginia, USA.
John R SaltzmanDivision of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Rebecca L SpitzerData Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Cathie SpinoDepartment of Public Health, University of Michigan, Ann Arbor, Michigan, USA.
B Joseph ElmunzerDivision of Gastroenterology & Hepatology, Medical University of South Carolina, Charleston, South Carolina, USA.
Georgios I PapachristouDivision of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
SVI Study Group

Funding

Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI TrialU01DK104833 · NIDDK · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI ELMUNZER, BADIH JOSEPH · 2015 to 2020
$11.5M
NIDDK NIH HHS U01 DK104833
6 · The paper itself

Abstract

BACKGROUND AND

aimsDifficult biliary cannulation (DBC) is a known risk factor for developing post-ERCP pancreatitis (PEP). To better understand how DBC increases PEP risk, we examined the interplay between technical aspects of DBC and known PEP risk factors.

methodsThis was a secondary analysis of a multicenter, randomized controlled trial comparing rectal indomethacin alone with the combination of rectal indomethacin and prophylactic pancreatic duct (PD) stent placement for PEP prophylaxis in high-risk patients. Participants were categorized into 3 groups: DBC with high preprocedure risk for PEP, DBC without high preprocedure risk for PEP, and non-DBC at high preprocedure risk for PEP.

resultsIn all, 1601 participants (84.1%) experienced DBC, which required a mean of 12 cannulation attempts (standard deviation, 10) and mean duration of 14.7 minutes (standard deviation, 14.9). PEP rate was highest (20.7%) in DBC with a high preprocedure risk, followed by non-DBC with a high preprocedure risk (13.5%), and then DBC without a high preprocedure risk (8.8%). Increasing number of PD wire passages (adjusted odds ratio [aOR], 1.97; 95% confidence interval [CI], 1.25-3.1) was associated with PEP in DBC, but PD injection, pancreatic sphincterotomy, and number of cannulation attempts were not associated with PEP. Combining indomethacin with PD stent placement lowered the risk of PEP (aOR, .61; 95% CI, .44-.84) in DBCs. This protective effect was evident in up to at least 4 PD wire passages.

conclusionsDBC confers higher PEP risk in an additive fashion to preprocedural risk factors. PD wire passages appear to add the greatest PEP risk in DBCs, but combining indomethacin with PD stent placement reduces this risk, even with increasing PD wire passages.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalCatheterizationCholangiopancreatography, Endoscopic RetrogradeIndomethacinPancreatitisStentsAdministration, RectalAgedFemaleHumansMaleMiddle AgedPancreatic DuctsRisk FactorsAnti-Inflammatory Agents, Non-SteroidalIndomethacin

Identifiers

PMID39389431
PMCPMC11875935

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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.