Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)

Browse trials for

• Pancreatitis 752

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 534 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Study arms

• Active comparator
  Rectal Indomethacin pre-ERCP

  Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP).

  Drug: Rectal indomethacin 100mg one time before or after ERCP

• Active comparator
  Rectal Indomethacin post-ERCP

  Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)

  Drug: Rectal indomethacin 100mg one time before or after ERCP

Interventions

• DrugRectal 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.

  Also known as: Indocid 100mg

Primary outcomes

1. Rate of Post-ERCP pancreatitis

   Time frame: 30 days

Secondary outcomes

1. Severity of Post-ERCP pancreatitis

   To evaluate the severity of post-ERCP pancreatitis between the 2 groups studied

   Time frame: 30 days

Publications

• 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. PubMed 17355281 ↗
• 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. PubMed 22494121 ↗
• 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. PubMed 12806612 ↗
• 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. PubMed 17883296 ↗