title: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02476279, registered June 2015.
authors.affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. elmunzer@musc.edu.
authors.forename: B Joseph
authors.initials: BJ
authors.lastname: Elmunzer
authors.affiliation: Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA. SerranoJ@extra.niddk.nih.gov.
authors.forename: Jose
authors.initials: J
authors.lastname: Serrano
authors.affiliation: Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA. Amitabh.Chak@uhhospitals.org.
authors.forename: Amitabh
authors.initials: A
authors.lastname: Chak
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA. SEdmundo@dom.wustl.edu.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Edmundowicz
authors.affiliation: Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. papachri@pitt.edu.
authors.forename: Georgios I
authors.initials: GI
authors.lastname: Papachristou
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA. jscheima@med.umich.edu.
authors.forename: James M
authors.initials: JM
authors.lastname: Scheiman
authors.affiliation: Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA. vsingh1@jhmi.edu.
authors.forename: Vikesh K
authors.initials: VK
authors.lastname: Singh
authors.affiliation: Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA. svaradarajulu@yahoo.com.
authors.forename: Shyam
authors.initials: S
authors.lastname: Varadarajulu
authors.affiliation: Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA. Vargoj@ccf.org.
authors.forename: John J
authors.initials: JJ
authors.lastname: Vargo
authors.affiliation: Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA. field.willingham@emoryhealthcare.org.
authors.forename: Field F
authors.initials: FF
authors.lastname: Willingham
authors.affiliation: Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. todd_baron@med.unc.edu.
authors.forename: Todd H
authors.initials: TH
authors.lastname: Baron
authors.affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. cotea@musc.edu.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Coté
authors.affiliation: Tidelands Health, Murrels Inlet, SC, USA. romagnuoloj@gmail.com.
authors.forename: Joseph
authors.initials: J
authors.lastname: Romagnuolo
authors.affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. woodap@musc.edu.
authors.forename: April
authors.initials: A
authors.lastname: Wood-Williams
authors.affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. depue@musc.edu.
authors.forename: Emily K
authors.initials: EK
authors.lastname: Depue
authors.affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. spitzer@musc.edu.
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Spitzer
authors.affiliation: Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA. spino@med.umich.edu.
authors.forename: Cathie
authors.initials: C
authors.lastname: Spino
authors.affiliation: Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. fosterl@musc.edu.
authors.forename: Lydia D
authors.initials: LD
authors.lastname: Foster
authors.affiliation: Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. durkalsv@musc.edu.
authors.forename: Valerie
authors.initials: V
authors.lastname: Durkalski
mesh_terms: D000285:Administration, Rectal; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects / Q000295:instrumentation*; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D014015:Tissue Banks; D016896:Treatment Outcome; D014481:United States
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007213:Indomethacin