CompletedNot Applicable

FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

United States552 participantsStarted 2016-11-16

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Compare the distribution of LSM at enrollment between participants with and without portal hypertension

Timeframe: Enrollment

Trial details

NCT IDNCT02922751

SponsorArbor Research Collaborative for Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-22

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