FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088819 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 13/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical trial to compare the use of intravenous fluid alone versus intravenous fluid with rectal indomethacin to prevent pancreatitis following ERCP procedure 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anshu Srivastava 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Dept of Pediatric Gastroenterology Sanjay Gandhi Postgraduate Institute of Medical Sciences Reabareli Road Lucknow, Uttar Pradesh, India PIN 226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904717  
Fax    
Email  anshusri@sgpgi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Anshu Srivastava 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Dept of Pediatric Gastroenterology Sanjay Gandhi Postgraduate Institute of Medical Sciences Reabareli Road Lucknow, Uttar Pradesh, India PIN 226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904717  
Fax    
Email  anshusri@sgpgi.ac.in  
 
Details of Contact Person
Public Query  
Name  Anshu Srivastava 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Dept of Pediatric Gastroenterology Sanjay Gandhi Postgraduate Institute of Medical Sciences Reabareli Road Lucknow, Uttar Pradesh, India PIN 226014

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904717  
Fax    
Email  anshusri@sgpgi.ac.in  
 
Source of Monetary or Material Support  
H Block Ground floor, Department of Pediatric Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow PIN 226014 
 
Primary Sponsor  
Name  Anshu Srivastava 
Address  Dept of Pediatric Gastroenterology Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow Uttar Pradesh, India. PIN 226014 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anshu Srivastava  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow,  Endoscopy room, H Block Ground floor, Department of Pediatric Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. PIN 226014
Lucknow
UTTAR PRADESH 		 8004904717

anshusri@sgpgi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, SGPGIMS, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aggressive hydration with ringer lactate  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 
Intervention  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 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 above 50 kg, 50 mg in 20-50 kg, 25 mg in less than 20 kg). Commonly used range of dose is 1-2 mg/kg (up to a maximum of 4 mg/kg or 200 mg) in 24 hours. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children up to 18 years of age undergoing ERCP for any indication (biliary or pancreatic). 
 
ExclusionCriteria 
Details  Severe anemia, Heart failure, Kidney disease, evidence of acute pancreatitis, contraindication to NSAID 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Severity of pancreatitis
Difference between pain score
Difference in hospital stay
Difference in side effects
 		 24 hours- 72 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
Close