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Steroids after surgery do not help infants with rare liver disease
Date:5/3/2014

isease Research and Education Network (ChiLDREN) at the NIH's National Institute of Diabetes and Digestive and Kidney Diseases.

START was conducted at 14 clinical centers. The study enrolled 140 infants with biliary atresia (mean age 10 weeks) between September 2005 and February 2011 and followed them until January 2013. Half were randomly assigned to receive steroids for 13 weeks. The other half received placebo. The drugs or placebo were started within 72 hours of the Kasai procedure, in which a surgeon removes the infant's damaged bile duct and attaches it to a loop of intestine to allow bile to flow from the liver to the small intestine. Without the surgery, infants with biliary atresia are unlikely to live past age 2 without a liver transplant.

Researchers found that steroids did not significantly improve bile flow in infants 6 months after surgery. Fifty-eight percent of infants on steroids achieved improved bile drainage compared to 48.6 percent of those in the placebo group. Results also revealed that survival rates were nearly the same, with 58 percent of infants treated with steroids and about 59 percent of infants receiving placebo still living with their own livers at age 2. While members of both groups had serious adverse events, 37 percent of those on steroids experienced their first complication within 30 days of surgery, compared to 19 percent in the placebo group. These adverse events included surgical complications, infections and bleeding in the digestive tract.

"These findings were unexpected and we hope that doctors who care for these infants thoroughly consider the risks and benefits of corticosteroids in these very vulnerable children," said Jorge A. Bezerra, M.D., lead author and professor of pediatrics of Cincinnati Children's Hospital Medical Center.

Biliary atresia affects about 1 out of every 5,000 to 18,000 infants and progresses to liver failure in more than 70 percent of babies with the dise
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Contact: Leslie Curtis
NIDDKMedia@mail.nih.gov
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
Source:Eurekalert

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