Primary Prophylaxis for Variceal Bleed in Biliary Atresia
Status:
Recruiting
Trial end date:
2022-06-15
Target enrollment:
Participant gender:
Summary
Biliary atresia is the commonest etiology of neonatal cholestasis and is the most common
indication for pediatric liver transplantation world-wide. Kasai-portoenterostomy (KPE) is
the operative procedure of choice which helps in restoration of biliary flow and preventing
rapid progression of fibrosis. Only 50-60% of infants have a successful surgery in terms of
normalization of bilirubin (<2 mg/dL) after 3 months. Remaining 40-50% have rapid progression
of PHT and eventual decompensation. Additionally, around 50-70% of infants with successful
KPE have 1 or more episodes of cholangitis, and the severe ones if left untreated lead to
progressive portal hypertension. Moreover in Indian setting a significant number of infants
with biliary atresia reach late when the KPE is not feasible, and this group develops very
rapid PHT and decompensation. Hence, overall around 70-80% of infants and children develop
PHT within 5 years of age. Variceal bleed has been shown to be an important determinant of
survival in infants with high bilirubin. Usage of beta-blockers in adult cirrhotics has been
shown to reduce the progression of varices and incidence of variceal bleed. Although many
pediatric hepatology centers worldwide use beta-blockers, there has been no controlled trial
specifically to address this issue in children with biliary atresia. So, we planned this
study to evaluate the efficacy of beta-blockers as primary prophylaxis for prevention of
variceal bleed in biliary atresia children.