A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis
Johns Hopkins University
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).
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 the established therapeutic benefit of the procedure. The most common complication of ERCP is the development of post-ERCP pancreatitis (PEP). Depending on whether the ERCP is performed in average or high-risk patients, the incidence of PEP ranges from 3-15%. The average Medicare reimbursement for PEP is approximately $6,000 and the estimated annual cost burden of PEP is in excess of $200 million. A…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTacrolimus capsule
Tacrolimus 5 mg PO, 1-2 hours prior to endoscopy
- DrugPlacebo
Placebo PO, 1-2 hours prior to endoscopy.
- DrugRectal Indomethacin
100 mg Rectal Indomethacin immediately after ERCP, in high-risk patients.
Locations (5)
- Johns Hopkins HospitalBaltimore, Maryland
- Asian Institute of GastroenterologyHyderabad, Andhra Pradesh
- Apollo Multispecialty Hospitals,Kolkata, West Bengal
- Post Graduate Institute of Medical Education and ResearchChandigarh
- Singapore General HospitalSingapore