Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

• Status: Completed
• Trial end date: 2016-12-02
• Target enrollment: 0
• Participant gender: All

Summary

This research is being done to see if using a combination of rectal indomethacin and epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: American Society for Gastrointestinal Endoscopy; Apollo Gleneagles Hospitals, Kolkata; Asian Institute of Gastroenterology, India; Postgraduate Institute of Medical Education and Research
• Treatments: Epinephrine; Epinephryl borate; Indomethacin; Racepinephrine

Criteria

Inclusion Criteria:

• Major inclusion criteria (If patients meet at least 1 of the criteria):

1. History of PEP

2. Pancreatic sphincterotomy

3. Pre-cut sphincterotomy

4. Difficult cannulation (>5 attempts / 10 minutes to cannulate)

5. Failed cannulation

6. Pneumatic dilation of an intact sphincter

7. Sphincter of Oddi dysfunction of Type I or Type II

• Minor inclusion criteria (If patients meet at least 2 of the criteria):

1. Age < 50 & Female gender

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

3. >/= 3 pancreatic injections (with at least 1 injection in 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. Breastfeeding mother

5. Standard contraindications to ERCP

6. Allergy / hypersensitivity to aspirin or NSAIDs or epinephrine

7. Chronic renal disease (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 mass

12. Receiving pancreatic duct stent placement for any indication

13. Procedure performed on major papilla/ventral pancreatic duct in patients with pancreas divisum

14. ERCP for pancreatic/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. Sphincter of Oddi dysfunction of Type III