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

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

Journal: Pancreas 2020;48(8):1061-1067

PMID: 31404020

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.

Address: From the Department of Medicine.; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.; Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.; Division of Gastroenterology, Hepatology, and Nutrition.; Comprehensive Cancer Center, The Ohio State University Wexner Medical Center, Columbus, OH.; Department of Medicine, University of California, San Francisco, San Francisco.; Department of Medicine, Keck School of Medicine of USC, Los Angeles, CA.; Division of Gastroenterology, Hepatology, and Nutrition.; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN.; Department of Medicine, University of Minnesota, Minneapolis, MN.; Department of Medicine, Dartmouth Geisel School of Medicine, Lebanon, NH.; Division of Gastroenterology and Hepatology, University Medical Center St Radboud, Nijmegen, Netherlands.; Saint Luke's GI Specialists, Saint Luke's Hospital, Kansas City, MO.; Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.; Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.; Department of Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada.; Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.; Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA.; Methodist Health System, Dallas, TX.; Division of Gastroenterology and Hepatology, University of Virginia, Charlottesville, VA.; Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.
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