Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Biliary Atresia, Alagille Syndrome, Alpha1 Anti-Trypsin Deficiency, Portal Hypertension, Liver Fibrosis, Cholestasis, transient elastography, pediatric liver disease, Liver Diseases, Liver Cirrhosis, Alpha 1-Antitrypsin Deficiency, Fibrosis, Liver Stiffness Measurement (LSM)

Eligibility

You can join if…

Open to people ages up to 21 years

  • Age less than 21 years at the time of enrollment
  • Participants enrolled in a ChiLDReN based prospective observational cohort study (PROBE, BASIC, or LOGIC)
  • Willingness and ability to participate in the study for up to 24 months
  • One of the following three diagnoses

You CAN'T join if...

  • BA with known situs inversus or polysplenia/asplenia
  • Presence of clinically significant ascites detected on physical examination
  • Open wound near expected FibroScan probe application site
  • Use of implantable active medical device such as a pacemaker or defibrillator
  • Known pregnancy
  • Prior liver transplant
  • Unable or unwilling to give informed consent or assent

Locations

  • University of California at San Francisco (UCSF)
    San Francisco California 94143 United States
  • Children's Hospital Los Angeles
    Los Angeles California 90027 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Arbor Research Collaborative for Health
Links
Childhood Liver Disease Research Network (ChiLDReN) website
ID
NCT02922751
Study Type
Observational
Participants
About 552 people participating
Last Updated