TY - JOUR
T1 - Sp H incterotomy for A cute R ecurrent P ancreatitis Randomized Trial
T2 - Rationale, Methodology, and Potential Implications
AU - Coté, Gregory A.
AU - Durkalski-Mauldin, Valerie L.
AU - Serrano, Jose
AU - Klintworth, Erin
AU - Williams, April W.
AU - Cruz-Monserrate, Zobeida
AU - Arain, Mustafa
AU - Buxbaum, James L.
AU - Conwell, Darwin L.
AU - Fogel, Evan L.
AU - Freeman, Martin L.
AU - Gardner, Timothy B.
AU - Van Geenen, Erwin
AU - Groce, J. Royce
AU - Jonnalagadda, Sreenivasa S.
AU - Keswani, Rajesh N.
AU - Menon, Shyam
AU - Moffatt, Dana C.
AU - Papachristou, Georgios I.
AU - Ross, Andrew
AU - Tarnasky, Paul R.
AU - Wang, Andrew Y.
AU - Wilcox, C. Mel
AU - Hamilton, Frank
AU - Yadav, Dhiraj
N1 - Publisher Copyright:
© Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - 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.
AB - 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.
KW - acute pancreatitis
KW - acute recurrent pancreatitis
KW - chronic pancreatitis
KW - endoscopic retrograde cholangiopancreatography
KW - pancreas divisum
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U2 - 10.1097/MPA.0000000000001370
DO - 10.1097/MPA.0000000000001370
M3 - Article
C2 - 31404020
AN - SCOPUS:85071303621
SN - 0885-3177
VL - 48
SP - 1061
EP - 1067
JO - Pancreas
JF - Pancreas
IS - 8
ER -