Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients
Condition: Post-ERCP Pancreatitis
MeSH terms: Pancreatitis
Intervention: Indomethacin; Placebo suppositories
Intervention description: 100 mg PR once at the time of ERCP; 2 placebo suppositories at the time of ERCP
Intervention MeSH terms: Indomethacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 602.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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