A Clinical trial to compare the use of intravenous fluid alone versus intravenous fluid with rectal indomethacin to prevent pancreatitis following ERCP procedure

Aggressive intravenous hydration with Ringer s Lactate alone or in combination with rectal indomethacin in prevention of post-ERCP pancreatitis in children - a randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088819

Enrollment

100

Registered

2025-06-13

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: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Intervention1: Aggressive hydration with ringer lactate and rectal indomethacin: All the patients will receive 1.5 times the hourly maintenance fluid per hour. The maintenance fluid will be calculated

Eligibility

Inclusion criteria

Inclusion criteria: Children up to 18 years of age undergoing ERCP for any indication (biliary or pancreatic).

Exclusion criteria

Exclusion criteria: Severe anemia, Heart failure, Kidney disease, evidence of acute pancreatitis, contraindication to NSAID

Design outcomes

Primary

Measure	Time frame
Proportion of patients developing post ERCP pancreatitis at 24 hours of procedureTimepoint: Proportion of patients developing post ERCP pancreatitis at 24 hours of procedure	—

Secondary

Measure	Time frame
Severity of pancreatitis Difference between pain score Difference in hospital stay Difference in side effects Timepoint: 24 hours- 72 hours	—

Countries

India

Contacts

Public ContactAnshu Srivastava

Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow

anshusri@sgpgi.ac.in8004904717

Outcome results

None listed

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