N/A
Completed N=180
Sonoelastography: Ultrasound Method to Measure Liver Fibrosis
Liver disease · Non-Alcoholic Fatty Liver Disease · Hepatitis C Virus (HCV) Coinfection · Hepatitis B Virus (HBV)
Source: ClinicalTrials.gov NCT01747772 ↗
Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Liver Elasticity Value Measured Using Sonoelastography (SE) — 7.225; 7.332; 8.548; 12.101 kilopascals (kPa)
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Elasticity Value Measured Using Sonoelastography (SE) |
7.225; 7.332; 8.548; 12.101; 10.469 | — |
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.
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. Informational only — not medical advice.