FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

Completed

Conditions studied: Biliary Atresia, Alagille Syndrome, Alpha1 Anti-Trypsin Deficiency, Portal Hypertension, Liver Fibrosis, Cholestasis

In brief

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.

Key facts

Study ID

NCT02922751

Run by

Arbor Research Collaborative for Health

People needed

552

Starts

2016-11-16

Expected to finish

2022-12-22

Last updated by the study team

2024-08-28

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• University of California at San Francisco (UCSF) — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta (Emory University) — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Cincinnati Children's Memorial Hospital — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital (Baylor College of Medicine) — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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