CompletedNot Applicable

FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)

United States, Canada552 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 range

21 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Biliary Atresia trials