NCT05252754 · Johns Hopkins University
Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis
(INTRO)
What this study is about
This research is being done to see if using taken by mouth tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).
View original scientific description
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).
Interventions
DRUG
Tacrolimus capsule
Tacrolimus 5 mg PO, 1-2 hours prior to endoscopy
DRUG
Placebo
Placebo PO, 1-2 hours prior to endoscopy.
DRUG
Rectal Indomethacin
100 mg Rectal Indomethacin immediately after ERCP, in high-risk patients.
Primary outcome measures
The proportion of subjects in each study group with Post ERCP Acute Pancreatitis (PEP)
Time frame: Within 30 days of ERCP
Incidence of PEP as defined by the consensus guidelines as 1. New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis 2. Amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure 3. Hospitalization or prolongation of existing hospitalization for at least 2 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 9, 2025 · Source of record for eligibility and locations