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

Conditions

• Post-ERCP Acute Pancreatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tacrolimus capsule — DRUG
  Tacrolimus 5 mg PO, 1-2 hours prior to endoscopy
• Placebo — DRUG
  Placebo PO, 1-2 hours prior to endoscopy.
• Rectal Indomethacin — DRUG
  100 mg Rectal Indomethacin immediately after ERCP, in high-risk patients.

Study Details

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).

Key Dates

Start date

Jan 18, 2023

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

4,874 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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

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

• Venkata S. Akshintala, M.D.
  +1 (410) 614-6708
  [email protected]

Locations (1)

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