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

PHASE3RecruitingINTERVENTIONAL
Enrollment

4,874

Participants

Timeline

Start Date

January 18, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Post-ERCP Acute Pancreatitis
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.

Trial Locations (5)

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

160012

NOT_YET_RECRUITING

Post Graduate Institute of Medical Education and Research, Chandigarh

169608

NOT_YET_RECRUITING

Singapore General Hospital, Singapore

500082

RECRUITING

Asian Institute of Gastroenterology, Hyderabad

700054

NOT_YET_RECRUITING

Apollo Multispecialty Hospitals,, Kolkata

All Listed Sponsors
lead

Johns Hopkins University

OTHER