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

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Rectal indomethacin 100mg one time before or after ERCP
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rectal Indomethacin pre-ERCP

Rectal Indomethacin post-ERCP

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of Post-ERCP pancreatitis

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2014
Last Updated
October 24, 2017
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT02111707
Brief Title
Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)
Official Title
Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rectal Indomethacin pre-ERCP
Arm Type
Active Comparator
Arm Description
Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP).
Arm Title
Rectal Indomethacin post-ERCP
Arm Type
Active Comparator
Arm Description
Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)
Intervention Type
Drug
Intervention Name(s)
Rectal indomethacin 100mg one time before or after ERCP
Other Intervention Name(s)
Indocid 100mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Post-ERCP pancreatitis
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Severity of Post-ERCP pancreatitis
Description
To evaluate the severity of post-ERCP pancreatitis between the 2 groups studied
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17355281
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. doi: 10.1111/j.1572-0241.2007.01165.x. Epub 2007 Mar 13.
Results Reference
result
PubMed Identifier
22494121
Citation
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.
Results Reference
result
PubMed Identifier
12806612
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. doi: 10.1016/s0016-5085(03)00384-6.
Results Reference
result
PubMed Identifier
17883296
Citation
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.
Results Reference
result

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

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