Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Post-ERCP Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT00820612
- Run by
- University of Michigan
- People needed
- 602
- Starts
- 2009-01-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2013-02-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Indiana University Medical Center — Indianapolis, Indiana, United States
- University of Kentucky — Lexington, Kentucky, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University Hospitals Case Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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