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Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis

RecruitingPhase 3Ages 18 Years - anyAllJohns Hopkins University
NCT05252754 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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).
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What it tests

  • Tacrolimus capsule
  • Placebo
  • Rectal Indomethacin
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Where

5 sites
Johns Hopkins Hospital
Baltimore, United States
Asian Institute of Gastroenterology
Hyderabad, India
Apollo Multispecialty Hospitals,
Kolkata, India
Post Graduate Institute of Medical Education and Research
Chandigarh, India
Singapore General Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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