Evidence map›Paper›PMID 26941086›Full record

Trial reportTrials2016

Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.

B Joseph Elmunzer, Jose Serrano, Amitabh Chak, Steven A Edmundowicz, Georgios I Papachristou, James M Scheiman, Vikesh K Singh, Shyam Varadarajulu, John J Vargo, Field F Willingham and 10 more

Erratum issued Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02476279 (Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
6.9field-weighted citation impact, top 3% 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
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 77 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Biliary and pancreatic stents.iGIE : innovation, investigation and insights · 2023
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. New insights into acute pancreatitis.Nature reviews. Gastroenterology & hepatology · 2019
    Review
  18. Article
  19. New Advances in the Treatment of Acute Pancreatitis.Current treatment options in gastroenterology · 2019
    Review
  20. Update on the Prevention of Post-ERCP Pancreatitis.Current treatment options in gastroenterology · 2018
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 12 institutions in 1 country.

B Joseph ElmunzerDivision of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. elmunzer@musc.edu.
Jose SerranoInstitute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA. SerranoJ@extra.niddk.nih.gov.
Amitabh ChakDivision of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA. Amitabh.Chak@uhhospitals.org.
Steven A EdmundowiczDivision of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA. SEdmundo@dom.wustl.edu.
Georgios I PapachristouDivision of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. papachri@pitt.edu.
James M ScheimanDivision of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA. jscheima@med.umich.edu.
Vikesh K SinghDivision of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA. vsingh1@jhmi.edu.
Shyam VaradarajuluCenter for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA. svaradarajulu@yahoo.com.
John J VargoDepartment of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA. Vargoj@ccf.org.
Field F WillinghamDivision of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA. field.willingham@emoryhealthcare.org.
Todd H BaronDivision of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. todd_baron@med.unc.edu.
Gregory A CotéDivision of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. cotea@musc.edu.
Joseph RomagnuoloTidelands Health, Murrels Inlet, SC, USA. romagnuoloj@gmail.com.
April Wood-WilliamsDivision of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. woodap@musc.edu.
Emily K DepueDivision of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. depue@musc.edu.
Rebecca L SpitzerDivision of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. spitzer@musc.edu.
Cathie SpinoDepartment of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA. spino@med.umich.edu.
Lydia D FosterData Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. fosterl@musc.edu.
Valerie DurkalskiData Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. durkalsv@musc.edu.
SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)
Medical University of South Carolina · USUniversity of Michigan–Ann Arbor · USAdventHealth Orlando · USCleveland Clinic · USEmory University · USJohns Hopkins University · USNational Institute of Diabetes and Digestive and Kidney Diseases · USTidelands Health · USUniversity Hospitals Case Medical Center · USUniversity of North Carolina at Chapel Hill · USUniversity of Pittsburgh Medical Center · USWashington University in St. Louis · 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
Stent vs. indomethacin for preventing post-ERCP pancreatitis (SVI study)U34DK099845 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ELMUNZER, BADIH JOSEPH · 2013 to 2013
$425k
NIDDK NIH HHS U01 DK104833NIDDK NIH HHS U01DK104833NIDDK NIH HHS U34 DK099845NIDDK NIH HHS U34DK099845
6 · The paper itself

Abstract

backgroundThe combination of prophylactic pancreatic stent placement (PSP) - a temporary plastic stent placed in the pancreatic duct - and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP. METHODS/

designThe SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked. DISCUSSION: The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough.

trial registrationNCT02476279, registered June 2015.

Indexed as

StentsAdministration, RectalAnti-Inflammatory Agents, Non-SteroidalCholangiopancreatography, Endoscopic RetrogradeClinical ProtocolsCombined Modality TherapyFemaleHumansIndomethacinMaleMiddle AgedPancreatitisResearch DesignRisk AssessmentRisk FactorsTime FactorsAnti-Inflammatory Agents, Non-SteroidalIndomethacin

Identifiers

PMID26941086
PMCPMC4778337
OpenAlexW2296083992

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.