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

Phase 3

Not yet recruiting

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

Registration Number: CTRI/2025/06/088819

Lead Sponsor: Anshu Srivastava

Brief Summary: This study is a single centre randomised controlled trial, comparing Aggressive intravenous hydration with Ringer’s Lactate alone or in combination with rectal indomethacin in prevention of post-ERCP pancreatitis. All the patients will receive 1.5 times the hourly maintenance fluid per hour. The maintenance fluid will be calculated based on the weight of the child using the Holiday-Segar formula. Half DNS will be used before ERCP and RL will be used during and post ERCP as the fluid of choice. The intervention arm will also receive rectal indomethacin within 60 minutes before ERCP. Dose of indomethacin will be based on the child’s weight (100 mg in > 50 kg, 50 mg in 20-50 kg, 25 mg in < 20 kg) as suggested by Troendle et al (12). Commonly used range of dose is 1-2 mg/kg (up to a maximum of 4 mg/kg or 200 mg) in 24 hours. Primary outcome will be Proportion of patients developing PEP in the two groups based on pain score and serum amylase and/or lipase at 24 hours. PEP will be defined as new or worsening pain abdomen combined with > 3 times upper limit of normal value of amylase or lipase at 24 hours post ERCP that requires or prolongs hospital stay. Secondary outcomes are Severity of pancreatitis between two groups, Difference between the mean duration of hospital stay in two groups, To assess the proportion of patients developing hyperamylasemia or hyperlipasemia, To measure the mean pain score in two groups, To measure any difference between side effects between two groups. Endpoints of the study will be all children completing the study protocol will be followed up (either telephonically or physically) on day 30 of recruitment for well-being status.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

Severe anemia, Heart failure, Kidney disease, evidence of acute pancreatitis, contraindication to NSAID.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing post ERCP pancreatitis at 24 hours of procedure	Proportion of patients developing post ERCP pancreatitis at 24 hours of procedure

Secondary Outcome Measures

Name	Time	Method
Severity of pancreatitis	Difference between pain score

Trial Locations

Locations (1): Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow,
🇮🇳
Lucknow, UTTAR PRADESH, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow,
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Anshu Srivastava
Principal investigator
8004904717
anshusri@sgpgi.ac.in