S-Shearwave Elastography for Assessment of Hepatic Fibrosis

Seoul National University

Status: Completed

Conditions: Liver Fibroses

Treatments: Diagnostic Test: S-Shearwave and TE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03047707

SNUH-2017-0215

Details and patient eligibility

About

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.

Enrollment: 634 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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634 participants in 1 patient group

S-Shearwave and TE

Experimental group

Treatment:

Diagnostic Test: S-Shearwave and TE