A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis
Who is this study for? Patients with Post-ERCP Acute Pancreatitis
What treatments are being studied? Rectal Indomethacin
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Other Locations
India
Post Graduate Institute of Medical Education and Research
NOT_YET_RECRUITING
Chandigarh
Asian Institute of Gastroenterology
RECRUITING
Hyderabad
Apollo Multispecialty Hospitals,
NOT_YET_RECRUITING
Kolkata
Singapore
Singapore General Hospital
NOT_YET_RECRUITING
Singapore
Contact Information
Primary
Venkata S. Akshintala, M.D.
vakshin1@jhmi.edu
+1 (410) 614-6708
Time Frame
Start Date: 2023-01-18
Estimated Completion Date: 2026-12
Participants
Target number of participants: 4874
Treatments
Experimental: Oral Tacrolimus + Indomethacin
* Tacrolimus Capsule 1-2 hours prior to the endoscopy~* Rectal Indomethacin immediately after ERCP, in high-risk patients
Placebo_comparator: Oral Placebo + Indomethacin
* Placebo Capsule 1-2 hours prior to the endoscopy~* Rectal Indomethacin immediately after ERCP, in high-risk patients
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University