Study to compare tacrolimus and rectal indomethacin for preventing pancreatitis after ERCP endoscopy procedure

Rectal Indomethacin, Oral TacROlimus, or their combination for the prevention of Post-ERCP pancreatitis (INTRO trial): Protocol for a randomized, controlled, double-blinded trial - INTRO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088301

Enrollment

4874

Registered

2025-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K858- Other acute pancreatitis

Interventions

Intervention1: Tacrolimus: 5 mg Tacrolimus one Capsule orally 1-2 hours before the ERCP procedure Intervention2: Indomethacin: One tablet of 100 mg rectal indomethacin immediately after ERCP in high-r

Eligibility

Inclusion criteria

Inclusion criteria: Any patient undergoing endoscopic retrograde cholangiopancreatography (ERCP) at any participating center, who is at least 18 years old and provides informed consent, can be included in the study.

Exclusion criteria

Exclusion criteria: 1. Unwillingness or inability to consent for the study. 2. Pregnancy 3. Breastfeeding mother 4. Chronic calcific pancreatitis 5. ERCP for biliary stent exchange or removal 6. ERCP in a patient with prior biliary sphincterotomy, but without anticipated pancreatogram. 7. Biliary intervention in a patient with pancreas divisum. 8. Standard contraindications to tacrolimus or NSAID use. 9. Current tacrolimus or immune modulator use. 10. Chronic kidney disease with GFR less than 30 or acute kidney injury. 11. Absence of rectum. 12. Acute pancreatitis within 30 days of ERCP. 13. Pancreatic head malignancy. 14. Sphincter of Oddi dysfunction (Type 3).

Design outcomes

Primary

Measure	Time frame
Incidence of post-ERCP pancreatitis as determined by independent adjudicators using the consensus criteria.Timepoint: On completion of study	—

Secondary

Measure	Time frame
The proportion of subjects in each study group with moderate-severe Post-ERCP Pancreatitis PEP severity grading will be based on the modified Atlanta Criteria. 1. Mild PEP: Hospitalizations less than three days without organ failure, local or systemic complications. 2. Moderate PEP: Hospitalization for four to ten days with transient organ failure that resolves within 48 hours and/or local or systemic complications. 3. Severe PEP: Hospitalization ten days with the development of pancreatic necrosis or pseudocyst, persistent single or multiple organ failure, and/or need for additional endoscopic, percutaneous, or surgical intervention of pancreatitis-related complications.Timepoint: Within 30 days of ERCP	—

Measure

Time frame

The proportion of subjects in each study group with moderate-severe Post-ERCP Pancreatitis PEP severity grading will be based on the modified Atlanta Criteria. 1. Mild PEP: Hospitalizations less than three days without organ failure, local or systemic complications. 2. Moderate PEP: Hospitalization for four to ten days with transient organ failure that resolves within 48 hours and/or local or systemic complications. 3. Severe PEP: Hospitalization ten days with the development of pancreatic necrosis or pseudocyst, persistent single or multiple organ failure, and/or need for additional endoscopic, percutaneous, or surgical intervention of pancreatitis-related complications.Timepoint: Within 30 days of ERCP

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Countries

India, Singapore, United States of America

Contacts

Public ContactSoumya Jagannath Mahapatra

All India Institute of Medical Sciences

soumyajagannath@yahoo.com9990420767

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026