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Eligibility
for people ages up to 21 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

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 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 Extracts Alpha 1-Antitrypsin

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
  • Biliary atresia per ChiLDReN criteria or,
  • Alpha-1 antitrypsin deficiency (PiZZ or SZ) or,
  • Alagille Syndrome per ChiLDReN criteria

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

  • Seattle Children's Hospital
    Seattle, Washington, 98105, United States
  • Children's Hospital Colorado
    Aurora, Colorado, 80045, United States
  • Texas Children's Hospital
    Houston, Texas, 77030, United States
  • Cincinnati Children's Memorial Hospital
    Cincinnati, Ohio, 60190, United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois, 60611, United States
  • Riley Hospital for Children
    Indianapolis, Indiana, 46202, United States
  • Children's Healthcare of Atlanta
    Atlanta, Georgia, 30322, United States
  • Hospital for Sick Children
    Toronto, Ontario, M5G 1X8, Canada

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Links
ChiLDReN Study Network Website
ID
NCT02922751
Study Type
Observational
Last Updated
February 1, 2017