About this trial
Biliary atresia is a rare, progressive liver disease that only affects infants. It leads to complete obstruction and scarring of the bile duct. Current non-invasive diagnostic tests have limited sensitivity.
Indocyanine Green (ICG) is a non-radioactive, fluorescent compound with several clinical applications including angiography for ophthalmologic testing, visualization during surgery, and measurement of liver function. After excitation with near infrared light (750-810 nm), ICG emits near infrared light at 850 nm, which can be detected by a special camera. ICG is taken up by the liver exclusively and excreted in the bile, where it is removed from the body in the stool. The hypothesis is that after injection of ICG, participants with biliary atresia will not have any fluorescence detected in the stool. Investigators aim to use ICG as a functional test of bile duct patency in participants with cholestasis being evaluated for biliary atresia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age <3 months viable infants
cholestasis (defined as direct bilirubin >1)
undergoing diagnostic HIDA scan to evaluate for biliary atresia
Disqualifiers
kidney disease (eGFR <60 mL/min/1.73m2)
grossly bloody stools
history of bowel surgery or disease
history of allergic reaction to ICG, iodine, or shellfish
Trial design
Single group
Treatments tested in this trial
Indocyanine Green (ICG)
DrugOne time Indocyanine Green (ICG) injection.
Treatment groups
Trial outcomes
Primary outcomes
Indocyanine green (ICG) fluorescence in stool
We will assess if there is presence or absence of ICG fluorescence in the stool 24 hours after injection. This will be done using fluorescent imaging (Stryker) and result confirmed by two study staff.
Sponsors and contacts
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