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Randomized, double‐blind, placebo‐controlled trial of corticosteroids after Kasai portoenterostomy for biliary atresia
Author(s) -
Davenport Mark,
Stringer Mark D.,
Tizzard Sarah A.,
McClean Patricia,
MieliVergani Giorgina,
Hadzic Nedim
Publication year - 2007
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.21873
Subject(s) - medicine , biliary atresia , gastroenterology , placebo , prednisolone , randomized controlled trial , bilirubin , liver transplantation , surgery , transplantation , alternative medicine , pathology
The objective of this study was to evaluate adjuvant corticosteroids after Kasai portoenterostomy for biliary atresia. The study consisted of a prospective, 2‐center, double‐blind, randomized, placebo‐controlled trial of post–Kasai portoenterostomy corticosteroids (oral prednisolone: 2 mg/kg/day from day 7 to day 21 and 1 mg/kg/day from day 22 to day 28). The data were compared with χ2 or Mann‐Whitney tests, as appropriate. Seventy‐one postoperative infants with type 3 biliary atresia were randomized to receive either oral prednisolone (n = 36) or a placebo (n = 37). At 1 month, the median bilirubin level was lower in the steroid group (66 versus 92 μmol/L, P = 0.06), but no difference was evident at 6 ( P = 0.56) or 12 ( P = 0.3) months. The proportion of infants with a normal bilirubin level (<20 μmol/L) at 6 (47% versus 49%, P = 0.89) and 12 months (50% versus 40%, P = 0.35) was not significantly different. The need for transplantation by 6 (12% versus 13%, P = 0.99) and 12 months (26% versus 35%, P = 0.47) was not significantly different. The steroid effect was more pronounced in younger infants (less than 70 days at Kasai portoenterostomy, n = 51), with a reduced bilirubin level at 1 month (64 versus 117 μmol/L, P = 0.01) and with a greater proportion with a normal bilirubin level at 12 months (54% versus 37%, P = 0.22). Conclusion: There was a beneficial effect on the rate of reduction of bilirubin in the early postoperative period (specifically in infants less than 70 days old at surgery), but this steroid regimen did not reduce the need for liver transplantation. (H EPATOLOGY 2007;46:1821–1827.)