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

Authors :
J. Royce Groce
Gregory A. Cote
Andrew S. Ross
James Buxbaum
Dana C. Moffatt
Shyam Menon
Paul R. Tarnasky
Jose Serrano
Dhiraj Yadav
Evan L. Fogel
Darwin L. Conwell
Martin L. Freeman
Erin Klintworth
C. Mel Wilcox
Erwin J M van Geenen
Mustafa A. Arain
Andrew Y. Wang
Sreenivasa S. Jonnalagadda
Georgios I. Papachristou
Frank A. Hamilton
Zobeida Cruz-Monserrate
Timothy B. Gardner
Rajesh N. Keswani
April W. Williams
Valerie Durkalski-Mauldin
Source :
Pancreas, Pancreas, 48, 8, pp. 1061-1067, Pancreas, 48, 1061-1067
Publication Year :
2019

Abstract

Contains fulltext : 215317.pdf (Publisher’s version ) (Closed access) 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.

Details

Language :
English
ISSN :
08853177
Database :
OpenAIRE
Journal :
Pancreas, Pancreas, 48, 8, pp. 1061-1067, Pancreas, 48, 1061-1067
Accession number :
edsair.doi.dedup.....ea13577890cd695eb60656551f096158