Evaluation of the Use of Granulocyte Colony Stimulating Factor (GCSF) in Post Kasai Type 3 Biliary Atresia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-1
SponsorNational Liver Institute, Egypt
About this trial
The aim of the study is to evaluate the use of Granulocyte Colony Stimulating Factor (GCSF) on the clinical and biochemical outcome of type 3 biliary atresia post kasai.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Infants with initial diagnosis of biliary atresia with biliary atresia score > 23.927 will be allocated for Kasai porto-enterostomy with intra-operative cholangiogram reaching type 3 biliary atresia anatomy as a final diagnosis.
Disqualifiers
Major cardiac, renal, pulmonary, neurological malformations or illnesses.
Hemoglobinopathies, such as sickle cell anemia
Active systemic infection.
White blood cell count > 20,000 cells/mm3.
Trial design
Design model
Parallel
Treatments tested in this trial
Granulocyte Colony-Stimulating Factor
Drug20 patients will receive subcutaneous GCSF at a daily dose of 10ug/kg for 3 consecutive days. It is administered within 3-4 days after the Kasai procedure.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: biliary atresia without GCSFNo intervention 0 interventions
Group B: biliary atresia with GCSFExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects with serum TBi (total bilirubin) ≥ 2 mg/dL at 3 months.
Proportion of subjects with serum TBi (total bilirubin) ≥ 2 mg/dL at 3 months will be analyzed using generalized linear mixed effects model (GLMM) with a logistic link function for the covariates as fixed effects, with study sites as random effect to control for site variability in management practices and patient characteristics. The covariates are potential confounders for poor outcome, such as age at the time of Kasai, presence of ductal plate malformation, cholangitis and possibly CMV IgM(cytomegalovirus immune globulin M antibodies) positivity.
Time frame
baselineSecondary outcomes
1
Differences in the proportion of subjects with cholangitis at 6 months.
Differences in the proportion of subjects with cholangitis at 6 months will be calculated using the generalized linear mixed effect model with logistic link function for the covariates described in the primary outcome, with study sites as random effect to control for site variability in management practices and patient characteristics.
Time frame
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Source ClinicalTrials.gov