TerminatedNot Applicable

Ultrasound Method to Measure Fibrosis of the Liver in Children

Stopped: The technology showed rapid acceptance in the general population and we halted our feasibility demonstration study.

United States24 participantsStarted 2010-06

Plain-language summary

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease. Specific Aims: To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.

Who can participate

Age range1 Year – 21 Years

SexALL

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Inclusion criteria: * Patients scheduled for random liver biopsy for routine staging of liver fibrosis * Pediatric patients patients (ages 1-21) * Girls or boys * Suspected liver disease * Consent to participate in the study Exclusion criteria: * Pregnancy * Acute illness/cognitive impairment resulting in inability to cooperate with ultrasound * Patients that do not consent to ultrasound guided liver biopsy. * Contraindications to liver biopsy (e.g. low platelets defined as a platelet count of less than 50,000, and hemophilia/coagulopathy as an INR higher than 1.5.)

What they're measuring

Measure Liver Elasticity Value Using Sonoelastography.

Timeframe: Day one

Trial details

NCT IDNCT02086708

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2016-10-05

View on ClinicalTrials.gov More Chronic Liver Disease trials