Efficacy and safety of post-Kasai steroid-based protocol in biliary atresia

This study aims to assess whether steroid-based regimen enhances the clearance of jaundice and improves native liver survival (NLS).

We included all infants with biliary atresia (BA) undergoing Kasai portoenterostomy (KPE) at our centre. The algorithm-initiated prednisolone was initiated if stools remained acholic.

Of 127 infants, 70 formed the steroid group (SG) and 57 the historical cohort (HC). Jaundice clearance at 6 months was superior with steroids (61.4% vs. 38.6%; odds ratio [OR] 2.53, 95% confidence interval [CI] 1.23-5.19, p = 0.013). Kaplan-Meier analysis demonstrated improved 24-month NLS (log-rank p = 0.044) in SG. Multivariate analysis identified younger age at KPE (adjusted odds ratio [aOR] 1.021 per day, 95% CI 1.004-1.038, p = 0.016), lower pre-operative bilirubin (aOR 1.163, 95% CI 1.024-1.320, p = 0.020) and steroid use (aOR 2.13, 95% CI 1.001-4.53, p = 0.050) as independent predictors of success.

Moderate-dose prednisolone after KPE enhances early bile drainage and prolongs native liver survival. Optimal benefit is achieved when surgery is performed at ≤70 days of age.

ClinicalTrials.gov identifier: NCT06447051 (Clinicaltrials.gov) https://clinicaltrials.gov/study/NCT06447051.