NCT05252754 Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
| NCT ID | NCT05252754 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Johns Hopkins University |
| Condition | Post-ERCP Acute Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,874 participants |
| Start Date | 2023-01-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 4,874 participants in total. It began in 2023-01-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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).
Contact & Investigator
Venkata S. Akshintala, M.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05252754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-ERCP Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05252754 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 4,874 participants.
Is NCT05252754 currently recruiting?
Yes, NCT05252754 is actively recruiting participants. Contact the research team at vakshin1@jhmi.edu for enrollment information.
Where is the NCT05252754 trial being conducted?
This trial is being conducted at Baltimore, United States, Hyderabad, India, Kolkata, India, Chandigarh, India and 1 additional location.
Who is sponsoring the NCT05252754 clinical trial?
NCT05252754 is sponsored by Johns Hopkins University. The principal investigator is Venkata S. Akshintala, M.D. at Johns Hopkins University. The trial plans to enroll 4,874 participants.