Sp H incterotomy for A cute R ecurrent P ancreatitis 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 RossPaul R. Tarnasky, Andrew Y. Wang, C. Mel Wilcox, Frank Hamilton, Dhiraj Yadav

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1061-1067
Number of pages7
JournalPancreas
Volume48
Issue number8
DOIs
StatePublished - Sep 1 2019

Keywords

  • acute pancreatitis
  • acute recurrent pancreatitis
  • chronic pancreatitis
  • endoscopic retrograde cholangiopancreatography
  • pancreas divisum

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Hepatology
  • Endocrinology

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  • Cite this

    Coté, G. A., Durkalski-Mauldin, V. L., Serrano, J., Klintworth, E., Williams, A. W., Cruz-Monserrate, Z., Arain, M., Buxbaum, J. L., Conwell, D. L., Fogel, E. L., Freeman, M. L., Gardner, T. B., Van Geenen, E., Groce, J. R., Jonnalagadda, S. S., Keswani, R. N., Menon, S., Moffatt, D. C., Papachristou, G. I., ... Yadav, D. (2019). Sp H incterotomy for A cute R ecurrent P ancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications. Pancreas, 48(8), 1061-1067. https://doi.org/10.1097/MPA.0000000000001370