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

• Published in: Pediatric surgery international 2021-08, Vol.37 (8), p.1089-1097
• Main Authors: Chen, Gong, Liu, Jia, Huang, YanLei, Wu, Ying, Lu, XueXin, Dong, Rui, Shen, Zhen, Sun, Song, Jiang, Jingying, Zheng, Shan
• Format: Article
• Language: English
• Subjects: Antibiotics; Clinical trials; Disease prevention; Families & family life; Liver diseases; Medical prognosis; Medicine; Medicine & Public Health; Original Article; Patients; Pediatric Surgery; Pediatrics; Surgery
• ISSN: 0179-0358; 1437-9813
• DOI: 10.1007/s00383-021-04916-z

Objective 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. Study design 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  = 90) and a long-term ( n  = 90) 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. Results The cholangitis incidence within 6-months post-Kasai in the short-term group was similar to the long-term group (62% vs. 70%, p  = 0.27) 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  = 0.02) and average episodes (2.4 ± 0.2 vs. 1.8 ± 0.1 episodes, p  = 0.01) of cholangitis were lower in the long-term group. Conclusion Long-term intravenous antibiotics can be replaced by the short-term regimen in the general protection against post-Kasai cholangitis.