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 Ross; Paul R. Tarnasky; Andrew Y. Wang; C. Mel Wilcox; Frank Hamilton; Dhiraj Yadav

doi:10.1097/MPA.0000000000001370

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

Medicine - Gastro, Hepatology, Nutrition Division

Research output: Contribution to journal › Article › peer-review

23 Scopus citations

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 language	English (US)
Pages (from-to)	1061-1067
Number of pages	7
Journal	Pancreas
Volume	48
Issue number	8
DOIs	https://doi.org/10.1097/MPA.0000000000001370
State	Published - Sep 1 2019

Bibliographical note

Funding Information:
Each author contributed to the conception and design of the study, revision of the manuscript, and approved the final version of the manuscript. Grant support from the National Institute of Diabetes and Digestive and Kidney Diseases: DK112673 (for the planning phase) and DK116743 (for the trial phase). The authors declare no conflict of interest. Clinical trials registration: ClinicalTrials.gov number NCT03609944. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/MPA.0000000000001370

Funding Information:
The SHARP trial is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and registered in clinicaltrials.gov (NCT 03609944). Recognizing the effort and skill required to execute the various aspects of a large clinical trial, the SHARP trial has 3 principal investigators, each having a specified focus. The administrative principal investigator (PI) (G.A.C.) oversees the work of the Clinical Coordinating Center and chairs the Steering, Publication, and Ancillary Study Committees. The protocol PI (D.Y.) chairs the Executive and Biorepository Committees and oversees the scientific aspects related to the trial protocol. The Statistical and Data Coordinating Center PI (V.L. D.-M.) is responsible for all aspects related to statistical design and analysis, study database development, and management and data reporting and sharing. A study-appointed independent medical safety monitor and an National Institutes of Health– NIDDK–appointed data and safety monitoring board (DSMB) oversee safety in the SHARP trial. The DSMB meets every 6 months to review study progress and accumulated data. Their main responsibilities are to ensure that study participants are not exposed to unnecessary or unreasonable risks and that the study is conducted with high scientific and ethical standards. The DSMB is assisted by the independent safety monitor who reviews and adjudicates all serious adverse events throughout the study.

Publisher Copyright:
© Wolters Kluwer Health, Inc. All rights reserved.

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1097/MPA.0000000000001370

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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

Coté, GA, Durkalski-Mauldin, VL, Serrano, J, Klintworth, E, Williams, AW, Cruz-Monserrate, Z, Arain, M, Buxbaum, JL, Conwell, DL, Fogel, EL, 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

@article{48d14f3aa0c0428781890f2328564659,

title = "Sp H incterotomy for A cute R ecurrent P ancreatitis Randomized Trial: Rationale, Methodology, and Potential Implications",

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.",

keywords = "acute pancreatitis, acute recurrent pancreatitis, chronic pancreatitis, endoscopic retrograde cholangiopancreatography, pancreas divisum",

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

note = "Funding Information: Each author contributed to the conception and design of the study, revision of the manuscript, and approved the final version of the manuscript. Grant support from the National Institute of Diabetes and Digestive and Kidney Diseases: DK112673 (for the planning phase) and DK116743 (for the trial phase). The authors declare no conflict of interest. Clinical trials registration: ClinicalTrials.gov number NCT03609944. Copyright {\textcopyright} 2019 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/MPA.0000000000001370 Funding Information: The SHARP trial is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and registered in clinicaltrials.gov (NCT 03609944). Recognizing the effort and skill required to execute the various aspects of a large clinical trial, the SHARP trial has 3 principal investigators, each having a specified focus. The administrative principal investigator (PI) (G.A.C.) oversees the work of the Clinical Coordinating Center and chairs the Steering, Publication, and Ancillary Study Committees. The protocol PI (D.Y.) chairs the Executive and Biorepository Committees and oversees the scientific aspects related to the trial protocol. The Statistical and Data Coordinating Center PI (V.L. D.-M.) is responsible for all aspects related to statistical design and analysis, study database development, and management and data reporting and sharing. A study-appointed independent medical safety monitor and an National Institutes of Health– NIDDK–appointed data and safety monitoring board (DSMB) oversee safety in the SHARP trial. The DSMB meets every 6 months to review study progress and accumulated data. Their main responsibilities are to ensure that study participants are not exposed to unnecessary or unreasonable risks and that the study is conducted with high scientific and ethical standards. The DSMB is assisted by the independent safety monitor who reviews and adjudicates all serious adverse events throughout the study. Publisher Copyright: {\textcopyright} Wolters Kluwer Health, Inc. All rights reserved.",

year = "2019",

month = sep,

day = "1",

doi = "10.1097/MPA.0000000000001370",

language = "English (US)",

volume = "48",

pages = "1061--1067",

journal = "Pancreas",

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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 - Funding Information: Each author contributed to the conception and design of the study, revision of the manuscript, and approved the final version of the manuscript. Grant support from the National Institute of Diabetes and Digestive and Kidney Diseases: DK112673 (for the planning phase) and DK116743 (for the trial phase). The authors declare no conflict of interest. Clinical trials registration: ClinicalTrials.gov number NCT03609944. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/MPA.0000000000001370 Funding Information: The SHARP trial is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and registered in clinicaltrials.gov (NCT 03609944). Recognizing the effort and skill required to execute the various aspects of a large clinical trial, the SHARP trial has 3 principal investigators, each having a specified focus. The administrative principal investigator (PI) (G.A.C.) oversees the work of the Clinical Coordinating Center and chairs the Steering, Publication, and Ancillary Study Committees. The protocol PI (D.Y.) chairs the Executive and Biorepository Committees and oversees the scientific aspects related to the trial protocol. The Statistical and Data Coordinating Center PI (V.L. D.-M.) is responsible for all aspects related to statistical design and analysis, study database development, and management and data reporting and sharing. A study-appointed independent medical safety monitor and an National Institutes of Health– NIDDK–appointed data and safety monitoring board (DSMB) oversee safety in the SHARP trial. The DSMB meets every 6 months to review study progress and accumulated data. Their main responsibilities are to ensure that study participants are not exposed to unnecessary or unreasonable risks and that the study is conducted with high scientific and ethical standards. The DSMB is assisted by the independent safety monitor who reviews and adjudicates all serious adverse events throughout the study. 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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JO - Pancreas

JF - Pancreas

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ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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