Objectives In 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. Methods The 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. Results The trial is powered to detect a 33% risk reduction of acute pancreatitis frequency. Conclusions The 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.
Bibliographical noteFunding Information:
Each author contributed to the conception and design of the study, revision of the manuscript, and approved the final version of the manuscript. Grant support from the National Institute of Diabetes and Digestive and Kidney Diseases: DK112673 (for the planning phase) and DK116743 (for the trial phase). The authors declare no conflict of interest. Clinical trials registration: ClinicalTrials.gov number NCT03609944. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/MPA.0000000000001370
The SHARP trial is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and registered in clinicaltrials.gov (NCT 03609944). Recognizing the effort and skill required to execute the various aspects of a large clinical trial, the SHARP trial has 3 principal investigators, each having a specified focus. The administrative principal investigator (PI) (G.A.C.) oversees the work of the Clinical Coordinating Center and chairs the Steering, Publication, and Ancillary Study Committees. The protocol PI (D.Y.) chairs the Executive and Biorepository Committees and oversees the scientific aspects related to the trial protocol. The Statistical and Data Coordinating Center PI (V.L. D.-M.) is responsible for all aspects related to statistical design and analysis, study database development, and management and data reporting and sharing. A study-appointed independent medical safety monitor and an National Institutes of Health– NIDDK–appointed data and safety monitoring board (DSMB) oversee safety in the SHARP trial. The DSMB meets every 6 months to review study progress and accumulated data. Their main responsibilities are to ensure that study participants are not exposed to unnecessary or unreasonable risks and that the study is conducted with high scientific and ethical standards. The DSMB is assisted by the independent safety monitor who reviews and adjudicates all serious adverse events throughout the study.
© Wolters Kluwer Health, Inc. All rights reserved.
Copyright 2019 Elsevier B.V., All rights reserved.
- acute pancreatitis
- acute recurrent pancreatitis
- chronic pancreatitis
- endoscopic retrograde cholangiopancreatography
- pancreas divisum