Preventive effect of prophylactic intravenous antibiotics against cholangitis in biliary atresia: a randomized controlled trial

Abstract

Biliary atresia (BA) is a neonatal liver disease and requires Kasai portoenterostomy. Many patients develop postoperative cholangitis, resulting in a poor prognosis. The preventive strategy of antibiotics is empirical and lacks a standard regimen. We aimed to analyze the effect of different durations of prophylactic intravenous antibiotics against post-Kasai cholangitis. A single-center, open-labeled, randomized clinical trial was performed from June 2016 to August 2017. One hundred and eighty BA patients were recruited and randomized into a short-term (n\u2009=\u200990) and a long-term (n\u2009=\u200990) treatment group, and prophylactic intravenous antibiotics were used for 7 versus 14 days, respectively. The primary outcome was the overall cholangitis incidence within 6-months post-Kasai portoenterostomy. The secondary outcomes included cholangitis incidence within 1 and 3 months post-Kasai portoenterostomy, the onset and average episodes of cholangitis, jaundice clearance rate, native liver survival rate, and adverse events within 6-months post-Kasai portoenterostomy. The cholangitis incidence within 6-months post-Kasai in the short-term group was similar to the long-term group (62% vs. 70%, p\u2009=\u20090.27) with intention-to-treat and pre-protocol analysis. There was no significant difference in jaundice clearance rate or native liver survival rate between the two groups. However, the percentage of early onset (61% vs. 38%, p\u2009=\u20090.02) and average episodes (2.4\u2009±\u20090.2 vs. 1.8\u2009±\u20090.1 episodes, p\u2009=\u20090.01) of cholangitis were lower in the long-term group. Long-term intravenous antibiotics can be replaced by the short-term regimen in the general protection against post-Kasai cholangitis.