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

Launched by JOHNS HOPKINS UNIVERSITY · Feb 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether taking oral tacrolimus before a procedure called ERCP (which examines the bile ducts and pancreas) can help prevent a condition known as post-ERCP pancreatitis, which is inflammation of the pancreas that can occur after the procedure. The trial is currently looking for participants who are at least 18 years old and will be undergoing an ERCP at one of the participating centers.

To be eligible, you should not be pregnant, breastfeeding, or have certain health conditions like chronic pancreatitis or severe kidney issues. If you decide to participate, you will receive either the tacrolimus, a medication, or a combination of other treatments to see which is more effective at preventing pancreatitis after the ERCP. This research could help improve care for patients undergoing this common procedure, so if you meet the criteria and are interested, you may want to talk to your healthcare provider for more information.

Gender

ALL

Eligibility 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).