RecruitingNCT05848310
Preoperative Serum FGF19 in the Prognosis of Biliary Atresia
Sponsor
Children's Hospital of Fudan University
Enrollment
200 participants
Start Date
Oct 15, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
To investigate the role of preoperative serum FGF19 level in the prognosis of biliary atresia.
Eligibility
Plain Language Summary
Simplified for easier understanding
This study investigates whether a blood protein called FGF19 (fibroblast growth factor 19) measured before surgery can predict outcomes in infants with biliary atresia — a rare and serious liver disease in newborns where the bile ducts are blocked or absent, causing dangerous bile buildup in the liver. The standard treatment is a surgery called the Kasai procedure, but outcomes vary widely: some children do well for years while others progress rapidly to liver failure requiring transplantation. Better biomarkers that predict which children will respond well to surgery would allow more personalized treatment planning and earlier liver transplant referral when needed.
Eligible samples must come from infants diagnosed with biliary atresia at Fudan University Children's Hospital who have at least one year of follow-up records after surgery and bilirubin measurements at three months post-surgery, along with sufficient stored preoperative serum. There are no exclusion criteria — all eligible stored samples will be analyzed.
This is a retrospective study examining stored blood samples alongside existing clinical records — no new procedures or interventions are required from participants. This research matters because biliary atresia, though rare, is the most common reason children undergo liver transplantation worldwide. Identifying a reliable blood biomarker measured before surgery could transform how clinicians counsel families, prioritize post-surgical monitoring, and time transplant listing — potentially improving survival and quality of life for these very young patients.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Locations(1)
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NCT05848310
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