Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Indocyanine green (ICG) fluorescence in stool
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 3 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age <3 months viable infants
- •cholestasis (defined as direct bilirubin >1)
- •undergoing diagnostic HIDA scan to evaluate for biliary atresia
排除标准
- •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
- •unable to provide informed consent
研究组 & 干预措施
Indocyanine Green (ICG)
All infants enrolled in this study will receive an injection of ICG
干预措施: Indocyanine Green (ICG) (Drug)
结局指标
主要结局
Indocyanine green (ICG) fluorescence in stool
时间窗: 24 hours after injection
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.
次要结局
未报告次要终点
研究者
Andrew Wehrman
Primary Investigator
Boston Children's Hospital
