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CTRI Number  CTRI/2025/08/092957 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Studying the role of G-CSF in children with Biliary Atresia after their first Surgery 
Scientific Title of Study   A pilot randomised controlled trial to assess the role of G-CSF in Biliary Atresia patients Post Kasai Portoenterostomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikunj Nandan  
Designation  Senior Resident MCh Student 
Affiliation  AIIMS NEW DELHI 
Address  Dept of Pediatric Surgery, Mother Child Block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9419982112  
Fax    
Email  nikunjnandan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjan Dhua 
Designation  Professor & Guide 
Affiliation  AIIMS NEW DELHI 
Address  Dept of Pediatric Surgery, Mother Child Block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  8368968257  
Fax    
Email  dhuaanjan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjan Dhua 
Designation  Professor & Guide 
Affiliation  AIIMS NEW DELHI 
Address  Dept of Pediatric Surgery, Mother Child Block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  8368968257  
Fax    
Email  dhuaanjan@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, ANSARI NAGAR, NEW DELHI 110029 
 
Primary Sponsor  
Name  AIIMS  
Address  Dept of Pediatric Surgery, Mother Child Block, AIIMS, Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Research institution and hospital 
 
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 Nikunj Nandan  AIIMS  Dept of Pediatric Surgery, Mother Child Block, AIIMS, Ansari Nagar, New Delhi 110029
South
DELHI 		 9419982112

nikunjnandan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K838||Other specified diseases of biliary tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  G-CSF  starting POD 3, 10 mcg/kg/day subcutaneous OD x 3 days (comparator group) 
Comparator Agent  Standard Therapy  Antibiotics, UDCA, Vitamin Supplements  
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  6.00 Month(s)
Gender  Both 
Details  Infants (50 days of life to 200 days of life) undergoing Kasai Porto Enterostomy (KPE) for Biliary Atresia

 
 
ExclusionCriteria 
Details  -Re-do KPE
-Major congenital anomalies, systemic illness or active infection
-Syndromic association
-Hematological Disorders
-Severe Laboratory Abnormalities
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome: Serum bilirubin levels (mg/dL) at three months and T Bilirubin at 3 months/T Bilirubin at KPE ratio  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcomes:No of episodes of cholangitis & CD34+ HSC levels (flow cytometry).
 		 3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   23/08/2025 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nikunjnandan@gmail.com].

  6. For how long will this data be available start date provided 01-12-2027 and end date provided 01-12-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The rationale of conducting this pilot study in India stems from the recognition of disease heterogeneity - a complex interplay of genetics, environmental & geographical factors that can influence the clinical presentation, progression, & treatment response of biliary atresia. While phase 1 trials from other countries have shown promising results, such data cannot be universally extrapolated without contextual validation. Genetic predispositions may be modulated by by local environmental exposures, dietary patterns, healthcare access & endemic pathogens, all of which differ significantly in India. Therefore, this pilot trial aims to generate early evidence of feasibility, safety & biological response specific to Indian Pediatric population, while also addressing the absence of published Phase 2 trial outcomes.  
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