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 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

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Pancreatitis
Endoscopic Sphincterotomy
Endoscopic Retrograde Cholangiopancreatography
Pancreas
Magnetic Resonance Cholangiopancreatography
Controlled Clinical Trials
Risk Reduction Behavior
Randomized Controlled Trials

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

Cite this

Coté, G. A., Durkalski-Mauldin, V. L., Serrano, J., Klintworth, E., Williams, A. W., Cruz-Monserrate, Z., ... 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

Sp H incterotomy for A cute R ecurrent P ancreatitis Randomized Trial : Rationale, Methodology, and Potential Implications. / 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; 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.

In: Pancreas, Vol. 48, No. 8, 01.09.2019, p. 1061-1067.

Research output: Contribution to journalArticle

Coté, GA, Durkalski-Mauldin, VL, Serrano, J, Klintworth, E, Williams, AW, Cruz-Monserrate, Z, Arain, M, Buxbaum, JL, Conwell, DL, Fogel, E, Freeman, ML, Gardner, TB, Van Geenen, E, Groce, JR, Jonnalagadda, SS, Keswani, RN, Menon, S, Moffatt, DC, Papachristou, GI, Ross, A, Tarnasky, PR, Wang, AY, Wilcox, CM, Hamilton, F & Yadav, D 2019, 'Sp H incterotomy for A cute R ecurrent P ancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications', Pancreas, vol. 48, no. 8, pp. 1061-1067. https://doi.org/10.1097/MPA.0000000000001370
Coté GA, Durkalski-Mauldin VL, Serrano J, Klintworth E, Williams AW, Cruz-Monserrate Z et al. Sp H incterotomy for A cute R ecurrent P ancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications. Pancreas. 2019 Sep 1;48(8):1061-1067. https://doi.org/10.1097/MPA.0000000000001370
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 ; 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. / Sp H incterotomy for A cute R ecurrent P ancreatitis Randomized Trial : Rationale, Methodology, and Potential Implications. In: Pancreas. 2019 ; Vol. 48, No. 8. pp. 1061-1067.
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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.",
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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

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

PY - 2019/9/1

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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.

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KW - acute pancreatitis

KW - acute recurrent pancreatitis

KW - chronic pancreatitis

KW - endoscopic retrograde cholangiopancreatography

KW - pancreas divisum

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