Evidence map›Paper›PMID 26775631›Full record

Trial reportGastroenterology2016

Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients.

John M Levenick, Stuart R Gordon, Linda L Fadden, L Campbell Levy, Matthew J Rockacy, Sarah M Hyder, Brian E Lacy, Steven P Bensen, Douglas D Parr, Timothy B Gardner

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

Trial report in Gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 69 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 12 pooled it
24.9field-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.

NCT01774604 phase3terminatednot on this map

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

TypeinterventionalSponsorDartmouth-Hitchcock Medical CenterRan2013 to 2014Enrolled449ConditionsPost-ERCP Acute PancreatitisArmsIndomethacin, Placebo
NCT03708458 phase4unknown statusnot on this mapstarted 2017, after this paper: background citation

Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis

TypeinterventionalSponsorGrigore T. Popa University of Medicine and PharmacyRan2017 to 2018Enrolled250ConditionsPost-ERCP PancreatitisArmsindomethacin suppository, N-acetylcysteine (NAC)
NCT05252754 phase3recruitingnot on this mapstarted 2023, after this paper: background citation

A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis

TypeinterventionalSponsorJohns Hopkins UniversityRan2023 to 2026Enrolled4,874ConditionsPost-ERCP Acute PancreatitisArmsTacrolimus capsule, Placebo, Rectal Indomethacin
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 12 syntheses or guidelines pooled it, 183 citations in OpenAlex.

  1. Pooled it
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  6. NSAIDs do not reduce severity among post-ERCP pancreatitis patients.Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2024
    Pooled it
  7. Nonsteroidal Anti-inflammatory Drugs for Endoscopic Retrograde Cholangiopancreatography Postoperative Pancreatitis Prevention: a Systematic Review and Meta-analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019
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  18. Why is the rectal route for NSAIDS favorable for preventing post-ERCP pancreatitis?Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2025
    Article
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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

John M LevenickSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; Section of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania. Electronic address: jlevenick@hmc.psu.edu.
Stuart R GordonSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Linda L FaddenSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
L Campbell LevySection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Matthew J RockacySection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Sarah M HyderSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Brian E LacySection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Steven P BensenSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Douglas D ParrInvestigational Pharmacy, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Timothy B GardnerSection of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Dartmouth–Hitchcock Medical Center · USPenn State Milton S. Hershey Medical Center · US

Funding

EUS Diagnosis of Chronic PancreatitisK23DK088832 · NIDDK · DARTMOUTH COLLEGE · PI GARDNER, TIMOTHY B. · 2010 to 2014
$804k
NIDDK NIH HHS 1K23DK088832NIDDK NIH HHS K23 DK088832
6 · The paper itself

Abstract

BACKGROUND &

aimsRectal indomethacin, a nonsteroidal anti-inflammatory drug, is given to prevent pancreatitis in high-risk patients undergoing endoscopic retrograde cholangiopancreatography (ERCP), based on findings from clinical trials. The European Society for Gastrointestinal Endoscopy guidelines recently recommended prophylactic rectal indomethacin for all patients undergoing ERCP, including those at average risk for pancreatitis. We performed a randomized controlled trail to investigate the efficacy of this approach.

methodsWe performed a prospective, double-blind, placebo-controlled trial of 449 consecutive patients undergoing ERCP at Dartmouth Hitchcock Medical Center, from March 2013 through December 2014. Approximately 70% of the cohort were at average risk for PEP. Subjects were assigned randomly to groups given either a single 100-mg dose of rectal indomethacin (n = 223) or a placebo suppository (n = 226) during the procedure. The primary outcome was the development of post-ERCP pancreatitis (PEP), defined by new upper-abdominal pain, a lipase level more than 3-fold the upper limit of normal, and hospitalization after ERCP for 2 consecutive nights.

resultsThere were no differences between the groups in baseline clinical or procedural characteristics. Sixteen patients in the indomethacin group (7.2%) and 11 in the placebo group (4.9%) developed PEP (P = .33). Complications and the severity of PEP were similar between groups. Per a priori protocol guidelines, the study was stopped owing to futility.

conclusionsIn a randomized controlled study of consecutive patients undergoing ERCP, rectal indomethacin did not prevent post-ERCP pancreatitis. ClincialTrials.gov no: NCT01774604.

Indexed as

Abdominal PainAdministration, RectalAnti-Inflammatory Agents, Non-SteroidalBiomarkersCholangiopancreatography, Endoscopic RetrogradeDouble-Blind MethodEarly Termination of Clinical TrialsFemaleHumansIndomethacinLipaseMaleMedical FutilityMiddle AgedNew HampshirePancreatitisAnti-Inflammatory Agents, Non-SteroidalBiomarkersIndomethacinLipasePNLIP protein, humanESGE RecommendationInflammationNSAIDPancreas

Identifiers

PMID26775631
PMCPMC4808426
OpenAlexW2225351396

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.