S-Shearwave Elastography for Assessment of Hepatic Fibrosis
Not Applicable
Completed
- Conditions
- Liver Fibroses
- Registration Number
- NCT03047707
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 634
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Diagnostic performance to detect severe hepatic fibrosis (F3) 3 months Reference standard: histologic diagnosis or Transient elastography
- Secondary Outcome Measures
Name Time Method 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 Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes 3 months Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis 3 months Intra-observer and inter-observer agreement of S-Shearwave measurements same day
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of