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

Field F Willingham, Valerie Durkalski, Lydia D Foster, Cathie Spino, Rebecca L Spitzer, Emily K Depue, April Wood-Williams, Joseph Romagnuolo, Gregory A Coté, Todd H Baron, B Joseph Elmunzer, John J Vargo, Shyam Varadarajulu, Vikesh K Singh, James M Scheiman, Georgios I Papachristou, Steven A Edmundowicz, Amitabh Chak, Jose Serrano

Journal: Trials 2016;17(1):120

PMID: 26941086

Free Full Text on BioMed Central View on PubMed

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.

Address: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. [email protected].; Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA. [email protected].; Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA. [email protected].; Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA. [email protected].; Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. [email protected].; Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA. [email protected].; Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA. [email protected].; Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA. [email protected].; Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA. [email protected].; Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA. [email protected].; Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. [email protected].; Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. [email protected].; Tidelands Health, Murrels Inlet, SC, USA. [email protected].; Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. [email protected].; Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. [email protected].; Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. [email protected].; Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA. [email protected].; Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. [email protected].; Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. [email protected].

DOI: 10.1186/s13063-016-1251-2

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https://assays.cancer.gov/non-CPTAC-3867

MeSH Terms: Administration, Rectal, Anti-Inflammatory Agents, Non-Steroidal, Cholangiopancreatography, Endoscopic Retrograde, Clinical Protocols, Combined Modality Therapy, Female, Humans, Indomethacin, Male, Middle Aged, Pancreatitis, Research Design, Risk Assessment, Risk Factors, Stents, Time Factors, Tissue Banks, Treatment Outcome, United States