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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111707
• Other study ID #: Pro00041158
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2014
• Last updated: October 24, 2017
• Start date: April 2014
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients referred for ERCP at the University of Alberta

• Age greater than 18 years

• Ability to provide written informed consent

Exclusion Criteria:

• Acute pancreatitis

• Active peptic ulcer disease

• Rectal disease

• Aspirin-induced asthma

• Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity

• Pregnancy

• Breast feeding

• Creatinine clearance < 30 ml/min

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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, Nichols — View Citation

Montaño Loza A, Rodríguez Lomelí X, García Correa JE, Dávalos Cobián C, Cervantes Guevara G, Medrano Muñoz F, Fuentes Orozco C, González Ojeda A. [Effect of the administration of rectal indomethacin on amylase serum levels after endoscopic retrograde chol — View Citation

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. — View Citation

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. Epub 2007 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Post-ERCP pancreatitis		30 days
Secondary	Severity of Post-ERCP pancreatitis	To evaluate the severity of post-ERCP pancreatitis between the 2 groups studied	30 days