Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Indomethacin; Tacrolimus

Criteria

Inclusion Criteria:

• Any patient who is undergoing endoscopic retrograde cholangiopancreatography (ERCP) at any of the participating centers, is at least 18 years old and provides informed consent can be included in the study.

Exclusion Criteria:

• Unwillingness or inability to consent for the study.

• Pregnancy

• Breastfeeding mother

• Chronic calcific pancreatitis

• ERCP for biliary stent exchange or removal

• ERCP in a patient with prior biliary sphincterotomy, but without anticipated pancreatogram.

• Biliary intervention in a patient with pancreas divisum.

• Standard contraindications to tacrolimus or NSAID use.

• Current tacrolimus or immune modulator use.

• Chronic kidney disease with glomerular filtration rate (GFR) < 30 or acute kidney injury.

• Absence of rectum.

• Acute pancreatitis within 30 days of ERCP.

• Pancreatic head malignancy.

• Sphincter of Oddi dysfunction (Type 3).