Ultrasound Method to Measure Fibrosis of the Liver in Children

Mass General Brigham

Status: Terminated

Conditions: Chronic Liver Disease; Drug-Induced Liver Injury; HBV; Non-Alcoholic Fatty Liver Disease; HCV Coinfection

Treatments: Device: Shear Wave sonoelastography

Study type: Interventional

Funder types: Other

Identifiers

NCT02086708

2010P000705

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Shear Wave Sonoelastography, Fibrosis stage

Experimental group

Description:

Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.

Treatment:

Device: Shear Wave sonoelastography