Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia: a Randomized Controlled Trial

What this Trial Is About

Biliary atresia (BA) is a serious inflammatory disease affecting bile ducts in newborns. After Kasai portoenterostomy (KP), a common treatment for BA, many patients develop cholangitis, an infection of the bile ducts. This trial investigates whether giving preventive oral antibiotics after KP reduces the rate of cholangitis compared to not using these antibiotics. The study is designed as a non-inferiority trial and follows patients for 2 years after their surgery to assess outcomes. Participants are randomly assigned to one of two groups. Both groups receive the same basic treatment including intravenous and oral medications such as sulperazone, ursodeoxycholic acid, compound glycyrrhizin, methylprednisolone, and vitamins. The antibiotics group additionally receives alternating doses of two oral antibiotics, compound sulfamethoxazole tablet and cefaclor, from 15 days after surgery until 6 months post-KP. The non-antibiotics group stops prophylactic antibiotics after surgery unless cholangitis occurs. The main focus is on measuring the occurrence of cholangitis within 6 months after KP. During the study, patients will be closely followed with regular visits and assessments over 2 years. Researchers will track cholangitis episodes, jaundice clearance, liver function, weight gain, and changes in intestinal flora at multiple time points. Laboratory tests and liver biopsies will be used to monitor liver health. The study evaluates both short-term and long-term effects to understand the benefits and risks of using preventive oral antibiotics after KP surgery in children with BA.

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy