Liver Fibroses
Conditions
Keywords
ultrasound elastography, S-Shearwave, liver, fibrosis
Brief summary
The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.
Interventions
DIAGNOSTIC_TESTS-Shearwave and TE
S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.
Sponsors
Samsung Medison
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers * Signed informed consent
Exclusion criteria
* Acute hepatitis or bile duct obstruction * Serum ALT\> 5 times the upper limit of normal within 3 months * s/p Rt. hemihepatectomy * s/p liver transplantation * Large mass or infiltrative lesion in the right lobe of the liver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance to detect severe hepatic fibrosis (F3) | 3 months | Reference standard: histologic diagnosis or Transient elastography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes | 3 months | — |
| Intra-observer and inter-observer agreement of S-Shearwave measurements | same day | — |
| Comparison of diagnostic performance: Shearwave vs. Transient elastography | 3 months | Reference standard: histologic diagnosis |
| Usefulness of auto-profile function in S-Shearwave measurements | 3 months | — |
| Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis | 3 months | — |
Countries
South Korea
Outcome results
None listed