Status:
RECRUITING
Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
Lead Sponsor:
Johns Hopkins University
Conditions:
Post-ERCP Acute Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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).
Detailed Description
Background: In the US alone, almost 700,000 endoscopic retrograde cholangiopancreatographies (ERCPs) are performed each year, and the utilization of ERCP over the last 10 years has increased due to th...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
4874 Patients enrolled
Trial Details
Trial ID
NCT05252754
Start Date
January 18 2023
End Date
December 1 2026
Last Update
December 9 2025
Active Locations (5)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, India, 500082
3
Apollo Multispecialty Hospitals,
Kolkata, West Bengal, India, 700054
4
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012