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Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial.
Trials. 2016 03 03; 17(1):120.T

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.

Authors+Show Affiliations

Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. elmunzer@musc.edu.Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA. SerranoJ@extra.niddk.nih.gov.Division of Gastroenterology, University Hospitals Case Medical Center, Cleveland, OH, USA. Amitabh.Chak@uhhospitals.org.Division of Gastroenterology, Washington University School of Medicine, St Louis, MO, USA. SEdmundo@dom.wustl.edu.Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. papachri@pitt.edu.Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI, USA. jscheima@med.umich.edu.Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA. vsingh1@jhmi.edu.Center for Interventional Endoscopy, Florida Hospital, Orlando, FL, USA. svaradarajulu@yahoo.com.Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH, USA. Vargoj@ccf.org.Division of Digestive Diseases, Emory University School of Medicine, Atlanta, GA, USA. field.willingham@emoryhealthcare.org.Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA. todd_baron@med.unc.edu.Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. cotea@musc.edu.Tidelands Health, Murrels Inlet, SC, USA. romagnuoloj@gmail.com.Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. woodap@musc.edu.Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. depue@musc.edu.Division of Gastroenterology and Hepatology, Medical University of South Carolina, MSC 702, 114 Doughty St., Suite 249, Charleston, SC, 29425, USA. spitzer@musc.edu.Department of Public Health, University of Michigan Medical School, Ann Arbor, MI, USA. spino@med.umich.edu.Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. fosterl@musc.edu.Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA. durkalsv@musc.edu.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

26941086

Citation

Elmunzer, B Joseph, et al. "Rectal Indomethacin Alone Versus Indomethacin and Prophylactic Pancreatic Stent Placement for Preventing Pancreatitis After ERCP: Study Protocol for a Randomized Controlled Trial." Trials, vol. 17, no. 1, 2016, p. 120.
Elmunzer BJ, Serrano J, Chak A, et al. Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial. Trials. 2016;17(1):120.
Elmunzer, B. J., Serrano, J., Chak, A., Edmundowicz, S. A., Papachristou, G. I., Scheiman, J. M., Singh, V. K., Varadarajulu, S., Vargo, J. J., Willingham, F. F., Baron, T. H., Coté, G. A., Romagnuolo, J., Wood-Williams, A., Depue, E. K., Spitzer, R. L., Spino, C., Foster, L. D., & Durkalski, V. (2016). Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial. Trials, 17(1), 120. https://doi.org/10.1186/s13063-016-1251-2
Elmunzer BJ, et al. Rectal Indomethacin Alone Versus Indomethacin and Prophylactic Pancreatic Stent Placement for Preventing Pancreatitis After ERCP: Study Protocol for a Randomized Controlled Trial. Trials. 2016 03 3;17(1):120. PubMed PMID: 26941086.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial. AU - Elmunzer,B Joseph, AU - Serrano,Jose, AU - Chak,Amitabh, AU - Edmundowicz,Steven A, AU - Papachristou,Georgios I, AU - Scheiman,James M, AU - Singh,Vikesh K, AU - Varadarajulu,Shyam, AU - Vargo,John J, AU - Willingham,Field F, AU - Baron,Todd H, AU - Coté,Gregory A, AU - Romagnuolo,Joseph, AU - Wood-Williams,April, AU - Depue,Emily K, AU - Spitzer,Rebecca L, AU - Spino,Cathie, AU - Foster,Lydia D, AU - Durkalski,Valerie, AU - ,, Y1 - 2016/03/03/ PY - 2015/09/24/received PY - 2016/02/23/accepted PY - 2016/3/5/entrez PY - 2016/3/5/pubmed PY - 2016/12/15/medline SP - 120 EP - 120 JF - Trials JO - Trials VL - 17 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/26941086/Rectal_indomethacin_alone_versus_indomethacin_and_prophylactic_pancreatic_stent_placement_for_preventing_pancreatitis_after_ERCP:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1251-2 DB - PRIME DP - Unbound Medicine ER -