Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborators: Case Western Reserve University; Indiana University School of Medicine; University of Kentucky
• Treatments: Indomethacin

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