Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05252754

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

Led by Johns Hopkins University · Updated on 2025-12-09

4874

Participants Needed

5

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) at participating centers
  • Age 18 years or older
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

  • Unwilling or unable to provide consent
  • Pregnancy
  • Breastfeeding
  • Chronic calcific pancreatitis
  • ERCP performed for biliary stent exchange or removal
  • ERCP in patients with prior biliary sphincterotomy without planned pancreatogram
  • Biliary intervention in patients with pancreas divisum
  • Standard contraindications to tacrolimus or NSAID use
  • Current use of tacrolimus or immune modulators
  • Chronic kidney disease with GFR less than 30 or acute kidney injury
  • Absence of rectum
  • Acute pancreatitis within 30 days before ERCP
  • Pancreatic head malignancy
  • Sphincter of Oddi dysfunction (Type 3)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

2

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, India, 500082

Actively Recruiting

3

Apollo Multispecialty Hospitals,

Kolkata, West Bengal, India, 700054

Not Yet Recruiting

4

Post Graduate Institute of Medical Education and Research

Chandigarh, India, 160012

Not Yet Recruiting

5

Singapore General Hospital

Singapore, Singapore, 169608

Not Yet Recruiting

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Research Team

V

Venkata S. Akshintala, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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