SpHincterotomy for Acute Recurrent Pancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications
Autor: | Coté, Gregory A, Durkalski-Mauldin, Valerie L, Serrano, Jose, Klintworth, Erin, Williams, April W, Cruz-Monserrate, Zobeida, Arain, Mustafa, Buxbaum, James L, Conwell, Darwin L, Fogel, Evan L, Freeman, Martin L, Gardner, Timothy B, van Geenen, Erwin, Groce, J Royce, Jonnalagadda, Sreenivasa S, Keswani, Rajesh N, Menon, Shyam, Moffatt, Dana C, Papachristou, Georgios I, Ross, Andrew, Tarnasky, Paul R, Wang, Andrew Y, Wilcox, C Mel, Hamilton, Frank, Yadav, Dhiraj, SHARP Consortium |
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Rok vydání: | 2019 |
Předmět: |
Adult
Male Internationality endoscopic retrograde cholangiopancreatography Outcome Assessment acute pancreatitis Clinical Trials and Supportive Activities Clinical Sciences acute recurrent pancreatitis Oral and gastrointestinal Endosonography Cohort Studies chronic pancreatitis SHARP Consortium Endoscopic Retrograde Recurrence Risk Factors Clinical Research Sphincterotomy Secondary Prevention Humans Magnetic Resonance pancreas divisum Pancreas Gastroenterology & Hepatology Prevention Cholangiopancreatography Health Care Pancreatitis Endoscopic Female Digestive Diseases |
Zdroj: | Pancreas, vol 48, iss 8 |
Popis: | ObjectivesIn 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.MethodsThe 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.ResultsThe trial is powered to detect a 33% risk reduction of acute pancreatitis frequency.ConclusionsThe 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. |
Databáze: | OpenAIRE |
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