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Studying the role of G-CSF in children with Biliary Atresia after their first Surgery

A pilot randomised controlled trial to assess the role of G-CSF in Biliary Atresia patients Post Kasai Portoenterostomy - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092957
Enrollment
20
Registered
2025-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K838- Other specified diseases of biliary tract

Interventions

Intervention1: G-CSF: starting POD 3, 10 mcg/kg/day subcutaneous OD x 3 days (comparator group) Control Intervention1: Standard Therapy: Antibiotics, UDCA, Vitamin Supplements

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants (50 days of life to 200 days of life) undergoing Kasai Porto Enterostomy (KPE) for Biliary Atresia

Exclusion criteria

Exclusion criteria: -Re-do KPE -Major congenital anomalies, systemic illness or active infection -Syndromic association -Hematological Disorders -Severe Laboratory Abnormalities

Design outcomes

Primary

MeasureTime frame
Primary Outcome: Serum bilirubin levels (mg/dL) at three months and T Bilirubin at 3 months/T Bilirubin at KPE ratioTimepoint: 3 months—

Secondary

MeasureTime frame
Secondary Outcomes:No of episodes of cholangitis & CD34+ HSC levels (flow cytometry). Timepoint: 3 months—

Countries

India

Contacts

Public ContactDr Anjan Dhua

AIIMS NEW DELHI

dhuaanjan@gmail.com8368968257

Outcome results

None listed

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