Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)
NCT ID: NCT02111707
Last Updated: 2017-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
534 participants
INTERVENTIONAL
2014-04-30
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Rectal Indomethacin pre-ERCP
Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP).
Rectal indomethacin 100mg one time before or after ERCP
Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.
Rectal Indomethacin post-ERCP
Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)
Rectal indomethacin 100mg one time before or after ERCP
Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.
Interventions
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Rectal indomethacin 100mg one time before or after ERCP
Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age greater than 18 years
* Ability to provide written informed consent
Exclusion Criteria
* Active peptic ulcer disease
* Rectal disease
* Aspirin-induced asthma
* Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity
* Pregnancy
* Breast feeding
* Creatinine clearance \< 30 ml/min
18 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Locations
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University of Alberta
Edmonton, Alberta, Canada
Countries
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References
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Sotoudehmanesh R, Khatibian M, Kolahdoozan S, Ainechi S, Malboosbaf R, Nouraie M. Indomethacin may reduce the incidence and severity of acute pancreatitis after ERCP. Am J Gastroenterol. 2007 May;102(5):978-83. doi: 10.1111/j.1572-0241.2007.01165.x. Epub 2007 Mar 13.
Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.
Murray B, Carter R, Imrie C, Evans S, O'Suilleabhain C. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology. 2003 Jun;124(7):1786-91. doi: 10.1016/s0016-5085(03)00384-6.
Montano Loza A, Rodriguez Lomeli X, Garcia Correa JE, Davalos Cobian C, Cervantes Guevara G, Medrano Munoz F, Fuentes Orozco C, Gonzalez Ojeda A. [Effect of the administration of rectal indomethacin on amylase serum levels after endoscopic retrograde cholangiopancreatography, and its impact on the development of secondary pancreatitis episodes]. Rev Esp Enferm Dig. 2007 Jun;99(6):330-6. doi: 10.4321/s1130-01082007000600005. Spanish.
Other Identifiers
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Pro00041158
Identifier Type: -
Identifier Source: org_study_id