A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
NCT ID: NCT02465138
Last Updated: 2022-04-28
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2023-11-30
2026-07-31
Brief Summary
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Determine if systemic mediators of inflammation are reduced in patients receiving IV ketorolac following ERCP.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Normal Saline will be administered prior to procedure.
Placebo
Intravenous saline
Toradol
Intravenous ketorolac prior to ERCP
Ketorolac
Intravenous ketorolac
Interventions
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Ketorolac
Intravenous ketorolac
Placebo
Intravenous saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-85
Exclusion Criteria
* Use of NSAIDs in the previous week
* Peptic ulcer disease
* Severe renal dysfunction
* Pregnancy
* Lithium therapy
* allergy to ketorolac
18 Years
85 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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John P Cello, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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San Francisco General Hospital
San Francisco, California, United States
UCSF/San Francisco General Hospital
San Francisco, California, United States
Countries
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References
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Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.
Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
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.
Otsuka T, Kawazoe S, Nakashita S, Kamachi S, Oeda S, Sumida C, Akiyama T, Ario K, Fujimoto M, Tabuchi M, Noda T. Low-dose rectal diclofenac for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a randomized controlled trial. J Gastroenterol. 2012 Aug;47(8):912-7. doi: 10.1007/s00535-012-0554-7. Epub 2012 Feb 18.
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.
Khoshbaten M, Khorram H, Madad L, Ehsani Ardakani MJ, Farzin H, Zali MR. Role of diclofenac in reducing post-endoscopic retrograde cholangiopancreatography pancreatitis. J Gastroenterol Hepatol. 2008 Jul;23(7 Pt 2):e11-6. doi: 10.1111/j.1440-1746.2007.05096.x. Epub 2007 Aug 7.
Dumonceau JM, Andriulli A, Deviere J, Mariani A, Rigaux J, Baron TH, Testoni PA; European Society of Gastrointestinal Endoscopy. European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis. Endoscopy. 2010 Jun;42(6):503-15. doi: 10.1055/s-0029-1244208. Epub 2010 May 26.
Cryer B, Feldman M. Cyclooxygenase-1 and cyclooxygenase-2 selectivity of widely used nonsteroidal anti-inflammatory drugs. Am J Med. 1998 May;104(5):413-21. doi: 10.1016/s0002-9343(98)00091-6.
Gillis JC, Brogden RN. Ketorolac. A reappraisal of its pharmacodynamic and pharmacokinetic properties and therapeutic use in pain management. Drugs. 1997 Jan;53(1):139-88. doi: 10.2165/00003495-199753010-00012.
Gross V, Leser HG, Heinisch A, Scholmerich J. Inflammatory mediators and cytokines--new aspects of the pathophysiology and assessment of severity of acute pancreatitis? Hepatogastroenterology. 1993 Dec;40(6):522-30.
Bhatia M, Brady M, Shokuhi S, Christmas S, Neoptolemos JP, Slavin J. Inflammatory mediators in acute pancreatitis. J Pathol. 2000 Feb;190(2):117-25. doi: 10.1002/(SICI)1096-9896(200002)190:23.0.CO;2-K.
Makela A, Kuusi T, Schroder T. Inhibition of serum phospholipase-A2 in acute pancreatitis by pharmacological agents in vitro. Scand J Clin Lab Invest. 1997 Aug;57(5):401-7. doi: 10.3109/00365519709084587.
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.
Cheon YK, Cho KB, Watkins JL, McHenry L, Fogel EL, Sherman S, Schmidt S, Lazzell-Pannell L, Lehman GA. Efficacy of diclofenac in the prevention of post-ERCP pancreatitis in predominantly high-risk patients: a randomized double-blind prospective trial. Gastrointest Endosc. 2007 Dec;66(6):1126-32. doi: 10.1016/j.gie.2007.04.012.
Senol A, Saritas U, Demirkan H. Efficacy of intramuscular diclofenac and fluid replacement in prevention of post-ERCP pancreatitis. World J Gastroenterol. 2009 Aug 28;15(32):3999-4004. doi: 10.3748/wjg.15.3999.
Dobronte Z, Toldy E, Mark L, Sarang K, Lakner L. [Effects of rectal indomethacin in the prevention of post-ERCP acute pancreatitis]. Orv Hetil. 2012 Jun 24;153(25):990-6. doi: 10.1556/OH.2012.29403. Hungarian.
Helleberg L. Clinical Pharmacokinetics of indomethacin. Clin Pharmacokinet. 1981 Jul-Aug;6(4):245-58. doi: 10.2165/00003088-198106040-00001.
Other Identifiers
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15-16365
Identifier Type: -
Identifier Source: org_study_id
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