Evidence map›Paper›PMID 31404020›Full record

ArticlePancreas2019

SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications.

Gregory A Coté, Valerie L Durkalski-Mauldin, Jose Serrano, Erin Klintworth, April W Williams, Zobeida Cruz-Monserrate, Mustafa Arain, James L Buxbaum, Darwin L Conwell, Evan L Fogel and 16 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Pancreas, 2019. 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 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.2field-weighted citation impact, top 6% 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.

NCT03609944 nacompletednot on this map

SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)

TypeinterventionalSponsorOregon Health and Science UniversityRan2018 to 2025Enrolled181ConditionsPancreatitis, Pancreas Divisum, Pancreatitis, Acute, Pancreatitis IdiopathicArmsERCP with miES, EUS
NCT05603702 phase1active not recruitingnot on this mapstarted 2023, after this paper: background citation

STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis

TypeinterventionalSponsorIndiana UniversityRan2023 to 2027Enrolled21ConditionsChronic Pain, Chronic Pain Syndrome, Chronic Pancreatitis, HyperalgesiaArmsLacosamide
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 47 citations in OpenAlex.

  1. Review
  2. Article
  3. Role of endoscopic retrograde cholangiopancreatography in pancreatitis.Journal of the Canadian Association of Gastroenterology · 2025
    Article
  4. Review
  5. Review
  6. Biliary and pancreatic stents.iGIE : innovation, investigation and insights · 2023
    Article
  7. Design and execution of sham-controlled endoscopic trials in acute pancreatitis: Lessons learned from the SHARP trial.Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2023
    Review
  8. Article
  9. Secretin-Enhanced MRCP: How and Why-AJR. American journal of roentgenology · 2021
    Review
  10. 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

26 authors at 16 institutions in 4 countries.

Gregory A CotéFrom the Department of Medicine.
Valerie L Durkalski-MauldinDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
Jose SerranoDivision of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.
Erin KlintworthDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
April W WilliamsDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
Zobeida Cruz-MonserrateDivision of Gastroenterology, Hepatology, and Nutrition.
Mustafa ArainDepartment of Medicine, University of California, San Francisco, San Francisco.
James L BuxbaumDepartment of Medicine, Keck School of Medicine of USC, Los Angeles, CA.
Darwin L ConwellDivision of Gastroenterology, Hepatology, and Nutrition.
Evan L FogelDepartment of Medicine, Indiana University School of Medicine, Indianapolis, IN.
Martin L FreemanDepartment of Medicine, University of Minnesota, Minneapolis, MN.
Timothy B GardnerDepartment of Medicine, Dartmouth Geisel School of Medicine, Lebanon, NH.
Erwin van GeenenDivision of Gastroenterology and Hepatology, University Medical Center St Radboud, Nijmegen, Netherlands.
J Royce GroceDivision of Gastroenterology, Hepatology, and Nutrition.
Sreenivasa S JonnalagaddaSaint Luke's GI Specialists, Saint Luke's Hospital, Kansas City, MO.
Rajesh N KeswaniDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Shyam MenonRoyal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.
Dana C MoffattDepartment of Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada.
Georgios I PapachristouDepartment of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Andrew RossDigestive Disease Institute, Virginia Mason Medical Center, Seattle, WA.
Paul R TarnaskyMethodist Health System, Dallas, TX.
Andrew Y WangDivision of Gastroenterology and Hepatology, University of Virginia, Charlottesville, VA.
C Mel WilcoxDepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL.
Frank HamiltonDivision of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.
Dhiraj YadavDepartment of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.
SHARP Consortium
Medical University of South Carolina · USNational Institute of Diabetes and Digestive and Kidney Diseases · USThe Ohio State University Wexner Medical Center · USDartmouth College · USIndiana University – Purdue University Indianapolis · USKeck Hospital of USC · USMethodist Dallas Medical Center · USNorthwestern University · USRadboud University Nijmegen · NLUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of Manitoba · CAUniversity of Pittsburgh · USUniversity of Virginia · USVirginia Mason Medical Center · USWolverhampton Hospital · GB

Funding

SpHincterotomy for Acute Recurrent PancreatitisU01DK116743 · NIDDK · OREGON HEALTH & SCIENCE UNIVERSITY · PI COTE, GREGORY A, DURKALSKI, VALERIE L · 2018 to 2022
$6.1M
Minor Endoscopic Sphincterotomy for Recurrent Acute Pancreatitis with Pancreas DivisumU34DK112673 · NIDDK · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI COTE, GREGORY A, YADAV, DHIRAJ · 2016 to 2016
$351k
NIDDK NIH HHS U01 DK116743NIDDK NIH HHS U34 DK112673
6 · The paper itself

Abstract

objectivesIn patients with acute recurrent pancreatitis (ARP), pancreas divisum, and no other etiologic factors, endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) is often performed to enlarge the minor papillary orifice, based on limited data. The aims of this study are to describe the rationale and methodology of a sham-controlled clinical trial designed to test the hypothesis that miES reduces the risk of acute pancreatitis.

methodsThe SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) trial is a multicenter, international, sham-controlled, randomized trial comparing endoscopic ultrasound + ERCP with miES versus endoscopic ultrasound + sham for the management of ARP. A total of 234 consented patients having 2 or more discrete episodes of acute pancreatitis, pancreas divisum confirmed by magnetic resonance cholangiopancreatography, and no other clear etiology for acute pancreatitis will be randomized. Both cohorts will be followed for a minimum of 6 months and a maximum of 48 months.

resultsThe trial is powered to detect a 33% risk reduction of acute pancreatitis frequency.

conclusionsThe SHARP trial will determine whether ERCP with miES benefits patients with idiopathic ARP and pancreas divisum. Trial planning has informed the importance of blinded outcome assessors and long-term follow-up.

Indexed as

Cholangiopancreatography, Endoscopic RetrogradeEndosonographyPancreasPancreatitisSphincterotomy, EndoscopicAdultCholangiopancreatography, Magnetic ResonanceCohort StudiesFemaleHumansInternationalityMaleMulticenter Studies as TopicObservational Studies as TopicOutcome Assessment, Health CareRandomized Controlled Trials as Topic

Identifiers

PMID31404020
PMCPMC6699897
OpenAlexW2968873507

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.