Research

Study for Infants with Biliary Atresia

A Randomized, Double-Blind, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants with Biliary Atresia

Protocol Description

The purpose of this study is to evaluate whether perioperative treatment with corticosteroids improves the outcome of infants following Kasai surgery for biliary atresia. Even after the Kasai operation, which removes scarred bile ducts, about 1 out of 2 patients will have severe liver damage by age 2 and may require a liver transplant. This research will help determine whether corticosteroid therapy can improve bile drainage and help prevent liver failure following the Kasai operation without causing serious side effects from the steroid medication itself.

This study is being conducted through the Childhood Liver Disease Research and Education Network (ChiLDREN), a network of 15 clinical sites in the United States and Canada.

Eligibility Criteria

All infants with biliary atresia up through 6 months of age who are scheduled to have Kasai surgery, or who have had Kasai surgery within the past 72 hours.
Boys: Newborn through 6 months
Girls: Newborn through 6 months

Requirements
Participants need to be enrolled in the Prospective Database of Infants with Cholestasis to be eligible for this study. Participants will randomly be placed into one of two groups. One group will receive the corticosteroid medication and the other group will receive a placebo. The study medication will be administered for 13 weeks following Kasai surgery, and participants will be examined at their regular follow-up clinic visits, usually scheduled at 1, 2, 3 and 6 months after surgery and then at 12, 18 and 24 months of age. An extra visit at 2 weeks after surgery also is required. Blood samples will be taken at the same time blood is drawn as part of the patient’s usual care following the Kasai operation. Parents/guardians keep a medical diary of the child’s condition during the study period.
Visits: 8
Duration: 24 months

Status: Open for Enrollment

Source of Support
National Institutes of Health

Additional Resources
Kasai Procedure
Biliary Atresia
Description of this study at the National Institutes of Health Web Site