Rectal Indomethacin in the Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
Information source: University of Michigan
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-ERCP Pancreatitis
Intervention: Indomethacin (Drug); Placebo suppositories (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Michigan Official(s) and/or principal investigator(s):
Badih J Elmunzer, MD, Principal Investigator, Affiliation: University of Michigan
Overall contact:
Badih J Elmunzer, MD, Phone: 734 615 6652, Email: badihe@umich.edu
Summary
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic
retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of
disorders of the pancreas and bile duct.
Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered
rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to
definitively determine whether rectally administered indomethacin (a non-steroidal
antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
Clinical Details
Official title: A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Incidence of post-ERCP pancreatitis
Detailed description:
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial
of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Included patients are those undergoing ERCP and have one of the following:
1. Clinical suspicion of sphincter of Oddi dysfunction
2. History of post-ERCP pancreatitis (at least one episode)
3. Pancreatic sphincterotomy
4. Pre-cut (access) sphincterotomy
5. > 8 cannulation attempts
6. Pneumatic dilation of intact biliary sphincter
7. Ampullectomy
or at least 2 of the following:
1. Age < 50 years old & female gender
2. History of recurrent pancreatitis (at least 2 episodes)
3. ≥3 pancreatic injections, with at least one injection to tail
4. Pancreatic acinarization
5. Pancreatic brush cytology
Exclusion Criteria:
1. Unwillingness or inability to consent for the study
2. Age < 18 years
3. Intrauterine pregnancy
4. Breast feeding mother
5. Standard contraindications to ERCP
6. Allergy to Aspirin or NSAIDs
7. Renal failure (Cr > 1. 4)
8. Active or recent (within 4 weeks) gastrointestinal hemorrhage
9. Acute pancreatitis (lipase peak) within 72 hours
10. Known chronic calcific pancreatitis
11. Pancreatic head malignancy
12. Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum
(no manipulation of minor papilla)
13. ERCP for biliary stent removal or exchange without anticipated pancreatogram
14. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy
without anticipated pancreatogram
15. Anticipated inability to follow protocol
16. Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis
Locations and Contacts
Badih J Elmunzer, MD, Phone: 734 615 6652, Email: badihe@umich.edu
Indiana University Medical Center, Indianapolis, Indiana 46202, United States; Not yet recruiting
Evan Fogel, MD, Email: efogel@iupui.edu
University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
Badih J Elmunzer, MD, Phone: 734-615-6652, Email: badihe@umich.edu
Badih J Elmunzer, MD, Principal Investigator
Additional Information
Starting date: January 2009
Ending date: December 2011
Last updated: January 9, 2009
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