Using Tacrolimus and Indomethacin to Prevent Pancreatitis After ERCP
A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis
PHASE3 · Johns Hopkins University · NCT05252754
This study is testing if taking a medication called tacrolimus before a procedure to remove bile duct stones can help prevent pancreatitis in patients.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 4874 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 5 sites (Baltimore, Maryland and 4 other locations) |
| Trial ID | NCT05252754 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether administering oral tacrolimus before endoscopic retrograde cholangiopancreatography (ERCP) can reduce the risk of post-ERCP pancreatitis. The study compares the effectiveness of tacrolimus combined with rectal indomethacin against a placebo in patients undergoing ERCP. Given the high incidence and cost burden of post-ERCP pancreatitis, this trial aims to explore a novel approach targeting the underlying mechanisms of this complication. The study will enroll patients who meet specific eligibility criteria and will be conducted at multiple locations, including Johns Hopkins Hospital and facilities in India.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled to undergo ERCP and can provide informed consent.
Not a fit: Patients with chronic pancreatitis, recent acute pancreatitis, or those with contraindications to tacrolimus or NSAIDs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of post-ERCP pancreatitis, improving patient outcomes and reducing healthcare costs.
How similar studies have performed: While some studies have explored preventative measures for post-ERCP pancreatitis, the use of tacrolimus in this context is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Baltimore, Maryland and 4 other locations
- Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
- Asian Institute of Gastroenterology — Hyderabad, Andhra Pradesh, India (RECRUITING)
- Apollo Multispecialty Hospitals, — Kolkata, West Bengal, India (NOT_YET_RECRUITING)
- Post Graduate Institute of Medical Education and Research — Chandigarh, India (NOT_YET_RECRUITING)
- Singapore General Hospital — Singapore, Singapore (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Venkata S. Akshintala, M.D. — Johns Hopkins University
- Study coordinator: Venkata S. Akshintala, M.D.
- Email: vakshin1@jhmi.edu
- Phone: +1 (410) 614-6708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-ERCP Acute Pancreatitis