Abstract:
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.
journal_name
Pancreasjournal_title
Pancreasauthors
Coté GA,Durkalski-Mauldin VL,Serrano J,Klintworth E,Williams AW,Cruz-Monserrate Z,Arain M,Buxbaum JL,Conwell DL,Fogel EL,Freeman ML,Gardner TB,van Geenen E,Groce JR,Jonnalagadda SS,Keswani RN,Menon S,Moffatt DC,Papachdoi
10.1097/MPA.0000000000001370subject
Has Abstractpub_date
2019-09-01 00:00:00pages
1061-1067issue
8eissn
0885-3177issn
1536-4828journal_volume
48pub_type
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