N/A N=180 Single-blind Diagnostic

Sonoelastography: Ultrasound Method to Measure Liver Fibrosis

Chronic Liver Disease · Non-Alcoholic Fatty Liver Disease · Hepatitis C Virus (HCV) Coinfection · Hepatitis B Virus (HBV) · Drug-Induced Liver Injury

Bottom Line

View on ClinicalTrials.gov: NCT01747772 ↗

Enrolled (actual)

180

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Liver Elasticity Value Measured Using Sonoelastography (SE) — 7.225; 7.332; 8.548; 12.101 kilopascals (kPa)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Shear Wave Sonoelastography (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Liver Elasticity Value Measured Using Sonoelastography (SE)	7.225; 7.332; 8.548; 12.101; 10.469	—

Summary

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease. 1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver disease who will undergo non-focal liver biopsy as part of their routine clinical care 2. To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis 3. To evaluate the effect of steatosis and inflammation on the estimation of liver fibrosis using sonoelastography

Eligibility Criteria

Inclusion Criteria

Adult patients (age 18 or older)
Men or women
Suspected diffuse 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 or sonoelastography.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01747772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.