S-Shearwave Elastography for Assessment of Hepatic Fibrosis

Seoul National University Hospital634 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

634

Conditions

Liver Fibroses

Interventions

S-Shearwave and TEDIAGNOSTIC_TEST

S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Diagnostic performance to detect severe hepatic fibrosis (F3)

Reference standard: histologic diagnosis or Transient elastography

Time frame: 3 months

Secondary Outcomes

Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes

Time frame: 3 months

Intra-observer and inter-observer agreement of S-Shearwave measurements

Time frame: same day

Comparison of diagnostic performance: Shearwave vs. Transient elastography

Reference standard: histologic diagnosis

Time frame: 3 months

Usefulness of auto-profile function in S-Shearwave measurements

Time frame: 3 months

Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis

Time frame: 3 months

Data from ClinicalTrials.gov

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