Multicenter randomized trial of postoperative corticosteroid therapy for biliary atresia.

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.

• Authors: Japanese Biliary Atresia Society, Masaki Nio, Toshihiro Muraji
• Journal: Pediatric surgery international (Pediatr Surg Int) Vol. 29 Issue 11 Pg. 1091-5 (Nov 2013) ISSN: 1437-9813 [Electronic] Germany
• PMID: 23989522 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Glucocorticoids
• Prednisolone

Topics

• Biliary Atresia (drug therapy, surgery)
• Dose-Response Relationship, Drug
• Female
• Follow-Up Studies
• Glucocorticoids (administration & dosage)
• Humans
• Infant
• Infant, Newborn
• Liver Function Tests
• Male
• Portoenterostomy, Hepatic (methods)
• Postoperative Care (methods)
• Postoperative Period
• Prednisolone (administration & dosage)
• Prospective Studies
• Treatment Outcome