Recruiting
Phase 3

Indomethacin & Tacrolimus

Sponsor:

Johns Hopkins University

Code:

NCT05252754

Conditions

Post-ERCP Acute Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tacrolimus capsule

Placebo

Rectal Indomethacin

Study Details

Brief 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).

Conditions

Post-ERCP Acute Pancreatitis

Study ID

NCT05252754

Start date

Jan 18, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

4874 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

Tacrolimus capsule

Tacrolimus 5 mg PO, 1-2 hours prior to endoscopy

Placebo

Placebo PO, 1-2 hours prior to endoscopy.

Rectal Indomethacin

100 mg Rectal Indomethacin immediately after ERCP, in high-risk patients.

Primary outcome measure

  • The proportion of subjects in each study group with Post ERCP Acute Pancreatitis (PEP) [ Time Frame: Within 30 days of ERCP ]

Central Contacts and Locations

Central contacts

Venkata S. Akshintala, M.D.

+1 (410) 614-6708vakshin1@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Venkata S Akshintala, M.D.

410-624-6955vakshin1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-12-09.