Effect of Adjuvant Steroid Therapy in type 3 Biliary Atresia: A Single-Center, Open-Label, Randomized Controlled Trial.

To evaluate the efficacy and side effects of additional postoperative steroid therapy for type 3 biliary atresia (BA) versus the current routine care.Whether steroid therapy post-Kasai portoenterostomy improves the outcomes of biliary atresia remains controversial. Clinical evidence from two randomized trials in the UK and USA do not support the routine use of steroid in the treatment of biliary atresia.In this open-label randomized controlled trial, patients with type 3 BA were randomized to routine postoperative treatment with or without 10-12weeks of adjuvant steroid treatment. The primary outcome was the postoperative jaundice clearance rate with native liver at 6 months. The secondary outcomes included postoperative jaundice clearance rate at 3, 12 and 24 months, survival with native liver at 12 and 24 months, and serious adverse events within 3 months.Overall, 200 participants were randomized and allocated into either steroid or control group (n = 100/group). The proportion of participants that are jaundice free without liver transplantation was significantly higher in the steroid group than in the control group at 6 months (54.1% vs 31.0%, P = 0.0015). The native liver survival rate was higher postoperatively in the steroid group than in the control group at 12 (66.3% vs 50.0%, P = 0.02) and 24 (57.1% vs 40.0%, P = 0.02) months. The survival time with native liver was significantly longer in the steroid group than in the control group (median survival, steroid vs control: not reached vs 1.21 years, P = 0.02). There were no significant differences between the two groups in the mean occurrence of serious adverse events within 3 months (steroid vs control: 0.63 vs 0.45, P = 0.20).Postoperative adjuvant steroid intervention improved bile drainage and survival with native liver in type 3 BA patients, without increasing early-stage serious adverse events.