Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis

After obtaining informed consent, subjects will undergo ERCP per clinical protocol. All
procedure-related clinical decisions and interventions will be dictated by the performing
physician as he or she sees fit. At the end of the procedure, it will be determined by the
endoscopist and research coordinator whether the patient meets inclusion criteria. If
inclusion criteria are met, subjects will be randomized by concealed allocation to receive
either 100mg or 150mg indomethacin, in the form of two or three 50mg rectal suppositories.
Those patients who are randomized to receive the 100mg dose will receive an additional
glycerin suppository. Four hours later, those patients who were randomized to the high-dose
group will then receive an additional 50mg suppository while in the recovery area. At this
same time point, subjects who were randomized to the standard-dose group, will receive a
glycerin suppository in the recovery area. All participating patients will receive a total of
4 suppositories.

Inclusion Criteria:

Included patients are those undergoing ERCP and have:

one of the following:

1. Clinical suspicion of sphincter of Oddi dysfunction (type I or II)

2. History of post-ERCP pancreatitis (at least one episode)

3. Pancreatic sphincterotomy

4. Pre-cut (access) sphincterotomy

5. >8 cannulation attempts of any sphincter

6. Pneumatic dilation of intact biliary sphincter

7. Ampullectomy 8.) Assessment for post-sphincterotomy stenosis

OR at least 2 of the following:

1. Age <50 years old and female gender

2. History of recurrent pancreatitis (at least 2 episodes)

3. > or = to 3 pancreatic injections, with at least 1 injection to tail

4. Pancreatic acinarization (excluding ventral pancreas of pancreas divisum)

5. Pancreatic brush cytology -

Exclusion Criteria:

1. Unwillingness or inability to consent for the study

2. Age < 18 years

3. Intrauterine pregnancy

4. Breastfeeding mother

5. Standard contraindications to ERCP

6. Allergy/hypersensitivity to aspirin or NSAIDs

7. Received NSAIDs in prior 7 days (aspirin 325mg or less ok)

8. Renal failure (Cr >1.4)

9. Active or recurrent (within 4 weeks) gastrointestinal hemorrhage

10. Acute pancreatitis (lipase peak) within 72 hours

11. Known chronic calcific pancreatitis

12. Pancreatic head mass

13. Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas
divisum (dorsal duct not attempted on injected)

14. ERCP for biliary stent removal or exchange without anticipated pancreatogram

15. Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy
without anticipated pancreatogram

16. Anticipated inability to follow protocol

17. Known active cardiovascular or cerebrovascular disease -