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Multicenter randomized trial of postoperative corticosteroid therapy for biliary atresia

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Abstract

Purpose

We aimed to evaluate early response to two different corticosteroids doses after Kasai portoenterostomy for biliary atresia (BA).

Methods

A prospective, randomized trial was performed in infants from the nationwide BA registry with type 3 BA. Sixty-nine infants were randomized to receive either 4 mg/kg/day (group A, n = 35) or 2 mg/kg/day prednisolone (group B, n = 34). The corticosteroids were started on postoperative day 7, and the dose was tapered toward day 30. Results of liver function tests on days 31 and 60 were compared between the groups.

Results

Mean bilirubin, AST, ALT, and GGT levels did not significantly differ between the groups. However, the levels of total and direct bilirubin of infants <70 days old at surgery significantly differed between the groups. Four patients from group A and five from group B, dropped out of the study. Complications during the first month after PE were comparable between the groups.

Conclusions

An initial 4 mg/kg/day dose did not significantly improve liver function, except that bilirubin levels were lower in the subgroup of infants <70 days old at surgery. There were no significant complications with either dose of corticosteroids.

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Acknowledgments

This work was supported by a Grant for Child Health and Development 17C-4 from Ministry of Health, Labour and Welfare. We are grateful to the member institutions of JBAS listed below and the many surgeons who extended their efforts to contribute to this prospective study and also each parent who gave consent for participation in this randomized trial. Institutions: Dr. kenji Iio, Aichi Prefectural Colony Central Hospital; Dr. Toshihiro Muraji, Ibaraki Children’s Hospital; Dr. Yutaka Hayashi, Miyagi Children’s Hospital; Dr. Shinji Uemoto, Kyoto University Hospital; Dr. Tomoaki Taguchi, Kyushu University Hospital; Dr. Kohji Oono, Saitama Medical University Hospital; Dr. Hiroo Uchida, Saitama Children’s Medical Center; Dr. Yasushi Iinuma, Niigata City General Hospital; Dr. Masayuki Kubota, Niigata University Hospital; Dr. Youkatsu Oohama, Kanagawa Children’s Medical Center; Dr. Yasuyuki Higashimoto, Chiba Children’s Hospital; Dr. Noritoshi Handa, Oita Prefectural Hospital; Dr. Kohji Masumoto, Tsukuba University Hospital; Dr. Tadashi Iwanaka, Tokyo University Hospital; Dr. Masaki Nio, Tohoku University Hospital; Dr. Tatsuya Suzuki, Fujita Health University Hospital; Dr. Akiko Yokoi, Hyogo Prefectural Kobe Children’s Hospital.

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Correspondence to Toshihiro Muraji.

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Japanese Biliary Atresia Society., Nio, M. & Muraji, T. Multicenter randomized trial of postoperative corticosteroid therapy for biliary atresia. Pediatr Surg Int 29, 1091–1095 (2013). https://doi.org/10.1007/s00383-013-3377-6

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  • DOI: https://doi.org/10.1007/s00383-013-3377-6

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