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Published on: May 16, 2025
Minimally invasive assessment of hepatic function in children with indocyanine green elimination: a validation study
Jon Nielsen1, Nikolaj Nerup2, Søren Møller3,4
1a Department of Paediatrics and Adolescent Medicine , Copenhagen University Hospital Rigshospitalet , Copenhagen Ø , Denmark.
Insights
A new minimally invasive method using pulse spectrophotometry accurately estimates Indocyanine Green (ICG) elimination in children with liver disease, offering a reliable alternative to blood sampling.
Area of Science:
- Pediatric Hepatology
- Diagnostic Technologies
- Biomedical Engineering
Background:
- Pediatric liver disease (PLD) presents diverse clinical scenarios, necessitating accurate severity assessment.
- Current methods for evaluating liver function, like Indocyanine Green (ICG) elimination kinetics, are often invasive, limiting their use in children.
- There is a clinical need for minimally invasive and reliable tools to assess hepatic function in pediatric patients.
Purpose of the Study:
- To evaluate the efficacy of a minimally invasive pulse spectrophotometry method (ICGLi) for estimating ICG elimination kinetics in children.
- To compare ICGLi with the traditional method of serial blood sampling (ICGbs) for measuring ICG elimination.
- To determine the correlation and agreement between the two methods for assessing liver function in pediatric patients.
Main Methods:
- One hundred children (aged 0-18 years) with various liver diseases were enrolled.
- ICG elimination kinetics were measured simultaneously using both ICGLi and ICGbs.
- Data were analyzed for failure rates, mean difference, limits of agreement, and linear regression to compare plasma disappearance rates (PDRLi and PDRbs).
Main Results:
- 112 simultaneous measurements were successfully completed in 87 patients.
- A strong linear correlation (regression coefficient 0.83) was observed between ICGLi and ICGbs.
- The derived equation PDRbs = 0.83 × PDRLi facilitates conversion between the two methods, despite a systematic difference.
Conclusions:
- Minimally invasive ICGLi can reliably replace serial blood sampling for ICG elimination assessment in children with PLD.
- The study identified a systematic relative difference between the methods, suggesting a need for a validated correction factor.
- Further validation in larger pediatric cohorts is recommended to confirm the utility of ICGLi and the proposed correction.
Abstract:
Objectives: Pediatric liver disease (PLD) covers a variety of etiologies and severities, from mild temporary illness to diseases with fatal outcomes. There is a demand for minimally invasive and reliable measures for assessment of the severity of PLD. Indocyanine green (ICG) elimination kinetics to estimate hepatic function has been used in adults for decades, however, due to invasiveness, the use in PLD is still limited. The aim of the present study was to evaluate minimally invasive estimation of ICG elimination by pulse spectrophotometry (ICGLi), in comparison with traditional spectrophotometry using serial blood samples (ICGbs). Methods: One hundred children aged 0-18 years were included in the study. ICG elimination kinetics was measured with ICGLi and ICGbs, and results compared by failure rates, mean difference, limits of agreement, Bland Altman plots and linear regression analysis. Plasma disappearance rates (PDRLi and PDRbs) were used for comparison. Results: One hundred and twelve simultaneous measurements in 87 patients were performed successfully. Mean difference for PDR (%/min) was 3.58 (95% CI 2.69; 4.47). Limits of agreement were -5.06; 12.22. A linear correlation between the two methods with a regression coefficient of 0.83 (SE 0.02 95% CI 0.80; 0.87) was found. For conversion we computed the following equation; PDRbs = 0.83 × PDRLi. Conclusions: The present study shows that ICG PDR can be obtained by a minimally invasive method and thus replace measures by serial blood samples in children with liver disease of different etiologies and severities. However, a systematic relative difference between the two methods exists. Our proposed correction factor needs to be validated in larger cohorts.
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