Evidence map›Paper›PMID 38219767›Full record

Trial reportLancet (London, England)2024

Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.

B Joseph Elmunzer, Lydia D Foster, Jose Serrano, Gregory A Coté, Steven A Edmundowicz, Sachin Wani, Raj Shah, Ji Young Bang, Shyam Varadarajulu, Vikesh K Singh and 29 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 42 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 5 pooled it
36.4field-weighted citation impact, top 1% of its field
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.

NCT02476279 phase3completednot on this map

Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis: The SVI Trial

TypeinterventionalSponsorMedical University of South CarolinaRan2015 to 2023Enrolled1,950ConditionsPost-ERCP PancreatitisArmsIndomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement, Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
NCT07117318 narecruitingnot on this mapstarted 2025, after this paper: background citation

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

42 citing papers in PubMed, 5 syntheses or guidelines pooled it, 87 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 2 countries.

B Joseph ElmunzerDivision of Gastroenterology & Hepatology, Medical University of South Carolina, Charleston, SC, USA. Electronic address: elmunzer@musc.edu.
Lydia D FosterData Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
Jose SerranoNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.
Gregory A CotéDivision of Gastroenterology & Hepatology, Oregon Health & Science University, Portland, OR, USA.
Steven A EdmundowiczDivision of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Sachin WaniDivision of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Raj ShahDivision of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Ji Young BangOrlando Health Digestive Health Institute, Orlando Health, Orlando, FL, USA.
Shyam VaradarajuluOrlando Health Digestive Health Institute, Orlando Health, Orlando, FL, USA.
Vikesh K SinghDivision of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Mouen KhashabDivision of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
Richard S KwonDivision of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA.
James M ScheimanDivision of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA.
Field F WillinghamDivision of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA.
Steven A KeilinDivision of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA.
Georgios I PapachristouDivision of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Amitabh ChakDivision of Gastroenterology, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Adam SlivkaDivision of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Daniel MulladyDivision of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA.
Vladimir KushnirDivision of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA.
James BuxbaumDivision of Gastroenterology, University of Southern California, Los Angeles, CA, USA.
Rajesh KeswaniDivision of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Timothy B GardnerSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Health, Lebanon, NH, USA.
Nauzer ForbesDivision of Gastroenterology, University of Calgary, Calgary, AB, Canada.
Amit RastogiDivision of Gastroenterology and Hepatology, University of Kansas Medical Center, Kansas City, KS, USA.
Andrew RossDivision of Gastroenterology, Virginia Mason Medical Center, Seattle, WA, USA.
Joanna LawDivision of Gastroenterology, Virginia Mason Medical Center, Seattle, WA, USA.
Patrick YachimskiDivision of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, TN, USA.
Yen-I ChenDivision of Gastroenterology, McGill University, Montreal, QC, Canada.
Alan BarkunDivision of Gastroenterology, McGill University, Montreal, QC, Canada.
Zachary L SmithDivision of Gastroenterology, Medical College of Wisconsin, Milwaukee, WI, USA.
Bret PetersenDepartment of Gastroenterology, Mayo Clinic, Rochester, MN, USA.
Andrew Y WangDivision of Gastroenterology, University of Virginia, Charlottesville, VA, USA.
John R SaltzmanDivision of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, MA, USA.
Rebecca L SpitzerDivision of Gastroenterology & Hepatology, Medical University of South Carolina, Charleston, SC, USA.
Collins OrdiahDivision of Gastroenterology & Hepatology, Medical University of South Carolina, Charleston, SC, USA.
Cathie SpinoDepartment of Public Health, University of Michigan, Ann Arbor, MI, USA.
Valerie Durkalski-MauldinData Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
SVI Study Group
Medical University of South Carolina · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Michigan–Ann Arbor · USEmory University · USJohns Hopkins University · USMcGill University · CAOrlando Health · USVirginia Mason Medical Center · USWashington University in St. Louis · USUniversity of Virginia · USBrigham and Women's Hospital · USDartmouth–Hitchcock Medical Center · USMayo Clinic in Arizona · USMedical College of Wisconsin · USNorthwestern University · USOregon Health & Science University · USThe Ohio State University Wexner Medical Center · USUniversity Hospitals of Cleveland · USUniversity of Calgary · CAUniversity of Kansas Medical Center · US

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

backgroundThe combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention.

methodsIn this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete.

findingsBetween Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6-6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups.

interpretationFor preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines.

fundingUS National Institutes of Health.

Indexed as

IndomethacinPancreatitisAdministration, RectalAdolescentAdultAnti-Inflammatory Agents, Non-SteroidalCholangiopancreatography, Endoscopic RetrogradeHumansRisk FactorsStentsAnti-Inflammatory Agents, Non-SteroidalIndomethacin

Identifiers

PMID38219767
PMCPMC10872215
OpenAlexW4390731794

What OpenQuestion holds

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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.