Status:
TERMINATED
Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Indiana University School of Medicine
University of Kentucky
Conditions:
Post-ERCP Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pa...
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 Criteria
Inclusion
- Included patients are those undergoing ERCP and have one of the following:
- Clinical suspicion of sphincter of Oddi dysfunction
- History of post-ERCP pancreatitis (at least one episode)
- Pancreatic sphincterotomy
- Pre-cut (access) sphincterotomy
- \> 8 cannulation attempts
- Pneumatic dilation of intact biliary sphincter
- Ampullectomy
- or at least 2 of the following:
- Age \< 50 years old \& female gender
- History of recurrent pancreatitis (at least 2 episodes)
- ≥3 pancreatic injections, with at least one injection to tail
- Pancreatic acinarization
- Pancreatic brush cytology
Exclusion
- Unwillingness or inability to consent for the study
- Age \< 18 years
- Intrauterine pregnancy
- Breast feeding mother
- Standard contraindications to ERCP
- Allergy to Aspirin or NSAIDs
- Renal failure (Cr \> 1.4)
- Active or recent (within 4 weeks) gastrointestinal hemorrhage
- Acute pancreatitis (lipase peak) within 72 hours
- Known chronic calcific pancreatitis
- Pancreatic head malignancy
- Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla)
- ERCP for biliary stent removal or exchange without anticipated pancreatogram
- Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
- Anticipated inability to follow protocol
- Endoscopist discretion: low risk (\<10%) of post-ERCP pancreatitis
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT00820612
Start Date
January 1 2009
End Date
July 1 2011
Last Update
February 28 2013
Active Locations (4)
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1
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
2
University of Kentucky
Lexington, Kentucky, United States, 40536
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106