Using Tacrolimus and Indomethacin to Prevent Pancreatitis After ERCP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can a rectal NSAID alone prevent pancreatitis after ERCP instead of also placing a pancreatic duct stent?

  This trial will see if giving a rectal NSAID by itself prevents pancreatitis after ERCP in high-risk adults as well as giving both a rectal NSAID and a pancreatic duct stent.

  Recruiting at 11 sites Air Force Military Medical University, China · Beijing, Beijing Municipality and 14 other locations · NCT07117318

• Using intravenous fluids to prevent pancreatitis after ERCP procedures

  This study tests if different types of intravenous fluids can help prevent pancreatitis in patients undergoing ERCP procedures.

  Recruiting Phase 4 University of Calgary · Calgary, Alberta · NCT06260878

• Understanding genetic and pharmacokinetic factors in post-ERCP pancreatitis

  This study is trying to find out how genetic factors and how the body processes medications affect the risk of developing pancreatitis after a specific procedure called ERCP.

  Recruiting Radboud University Medical Center · Nijmegen, Gelderland · NCT05267379

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.