Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial Public Deposited

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Creator
  • Elmunzer, B. J
    • Other Affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC 29425, USA
  • Chak, Amitabh
    • Other Affiliation: Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA
  • Edmundowicz, Steven A
    • Other Affiliation: Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA
  • Papachristou, Georgios I
    • Other Affiliation: Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
  • Varadurajulu, Shyam
    • Other Affiliation: Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA
  • Scheiman, James M
    • Other Affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA
  • Depue, Emily K
    • Other Affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC 29425, USA
  • Serrano, Jose
    • Other Affiliation: Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA
  • Willingham, Field F
    • Other Affiliation: Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA
  • Durkalski, Valerie
    • Other Affiliation: Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA
  • Baron, Todd H
    • Affiliation: School of Medicine, Department of Medicine, Division of Gastroenterology and Hepatology
  • Foster, Lydia D
    • Other Affiliation: Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA
  • Romagnuolo, Joseph
    • Other Affiliation: Tidelands Health, Murrels Inlet, SC, USA
  • Singh, Vikesh K
    • Other Affiliation: Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
  • Spino, Cathie
    • Other Affiliation: Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA
  • Coté, Gregory A
    • Other Affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC 29425, USA
  • Wood-Williams, April
    • Other Affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC 29425, USA
  • Vargo, John J
    • Other Affiliation: Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA
  • Spitzer, Rebecca L
    • Other Affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC 29425, USA
Abstract
  • Abstract Background The combination of prophylactic pancreatic stent placement (PSP) – a temporary plastic stent placed in the pancreatic duct – and rectal non-steroidal anti-inflammatory drugs (NSAIDs) is recommended for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. Preliminary data, however, suggest that PSP may be unnecessary if rectal NSAIDs are administered. Given the costs and potential risks of PSP, we aim to determine whether rectal indomethacin obviates the need for pancreatic stent placement in patients undergoing high-risk ERCP. Methods/Design The SVI (Stent vs. Indomethacin) trial is a comparative effectiveness, multicenter, randomized, double-blind, non-inferiority study of rectal indomethacin alone versus the combination of rectal indomethacin and PSP for preventing PEP in high-risk cases. One thousand four hundred and thirty subjects undergoing high-risk ERCP, in whom PSP is planned solely for PEP prevention, will be randomized to indomethacin alone or combination therapy. Those who are aware of study group assignment, including the endoscopist, will not be involved in the post-procedure care of the patient for at least 48 hours. Subjects will be assessed for PEP and its severity by a panel of independent and blinded adjudicators. Indomethacin alone will be declared non-inferior to combination therapy if the two-sided 95 % upper confidence bound of the treatment difference is less than 5 % between the two groups. Biological specimens will be obtained from trial participants and centrally banked. Discussion The SVI trial is designed to determine whether PSP remains necessary in the era of NSAIDs pharmacoprevention. The associated bio-repository will establish the groundwork for important scientific breakthrough. Trial registration NCT02476279, registered June 2015.
Date of publication
Identifier
  • doi:10.1186/s13063-016-1251-2
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • Elmunzer et al.
Language
  • English
Bibliographic citation
  • Trials. 2016 Mar 03;17(1):120
Publisher
  • BioMed Central
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