NCT02922751

FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

Childhood Liver Disease Research Network (ChiLDReN): FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE) Study Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 552 (actual)
• Sponsor: Arbor Research Collaborative for Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely performed because of inherent invasiveness and risks. This study will evaluate the role of non-invasive FibroScan™ technology to detect and quantify liver fibrosis.

Detailed description

Noninvasive monitoring of liver fibrosis is an unmet and critical need within the clinical management of children with chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation of children with liver disease, subsequent surveillance liver biopsy is rarely performed in children because of its inherent invasiveness and risks. Therefore, our understanding of the natural history of fibrosis progression in children is limited. The patchy nature of fibrosis in many important pediatric liver diseases \[e.g. biliary atresia (BA) and cystic fibrosis liver disease (CFLD)\] limits the utility of sequential liver biopsy even if it were to be employed in clinical practice in pediatrics. Thus, non-invasive means of assessing liver fibrosis throughout the liver would be highly desirable and clinically useful in pediatric hepatology. ChiLDReN is poised and uniquely qualified to conduct a comprehensive longitudinal assessment of the utility of FibroScan™-specific elastography, liver stiffness measurement (LSM) as a measure of hepatic fibrosis in children with serious chronic cholestatic liver disease.

Conditions

• Biliary Atresia
• Alagille Syndrome
• Alpha1 Anti-Trypsin Deficiency
• Portal Hypertension
• Liver Fibrosis
• Cholestasis

Interventions

Type	Name	Description
OTHER	Liver Stiffness Measurement (LSM)	LSM will be measured via transient elastography utilizing the non-invasive FibroScan™ ultrasound device. LSM will be measured at Baseline, Year 1 and Year 2 visits.

Timeline

• Start date: 2016-11-16
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2016-10-04
• Last updated: 2024-08-28

Locations

13 sites across 2 countries: United States, Canada