Design and execution of sham-controlled endoscopic trials in acute pancreatitis: Lessons learned from the SHARP trial

SHARP Consortium

Research output: Contribution to journalReview articlepeer-review

2 Scopus citations

Abstract

Using the ongoing NIDDK-funded multicenter randomized clinical trial, Sphincterotomy for Acute Recurrent Pancreatitis (SHARP) as an example, this article discusses the rationale and key aspects of study design that need to be considered when conducting a clinical trial of endoscopic therapy in acute pancreatitis. SHARP, the first trial using a sham ERCP in the placebo group, is designed to address a decades long controversy in clinical pancreatology, i.e. whether minor papilla sphincterotomy benefits patients with idiopathic acute recurrent pancreatitis who also have pancreas divisum. Although the trial has already enrolled and randomized over 5 times the number of subjects enrolled in the only randomized trial in this area published in 1992 (107 vs. 19), recruitment has been challenging and we are at ∼46% of target recruitment. The review discusses the challenges in the execution of the trial and strategies the SHARP team has used to address these, which investigators planning or considering treatment trials in pancreatitis may find helpful. It will also inform the general gastroenterologists the importance of discussing and referring potentially eligible subjects to centers participating in clinical trials. Developing evidence-based treatment will provide a solid scientific basis for physicians to recommend evidence-based treatments for pancreatitis.

Original languageEnglish (US)
Pages (from-to)187-191
Number of pages5
JournalPancreatology
Volume23
Issue number2
DOIs
StatePublished - Mar 2023

Bibliographical note

Funding Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) under award number U01DK116743 (GAC, VDM, DY). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Publisher Copyright:
© 2022 IAP and EPC

Keywords

  • Clinical trial
  • Pancreas divisum
  • Pancreatitis
  • SHARP

PubMed: MeSH publication types

  • Journal Article
  • Review

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