FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE) — FORCE  

Portal Hypertension Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alagille Syndrome
• Alpha 1-Antitrypsin Deficiency
• Alpha1 Anti-Trypsin Deficiency
• Biliary Atresia
• Cholestasis
• Fibrosis
• Hypertension, Portal
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Portal Hypertension

• NCT number: NCT02922751
• Study type: Observational
• Source: Arbor Research Collaborative for Health
• Status: Active, not recruiting
• Start date: November 16, 2016
• Completion date: December 2024