Comparison of Smart-Shear Wave Elastography and Transient Elastography (SMART)

Asan Medical Center

Status: Unknown

Conditions: Fibrosis, Liver

Treatments: Procedure: Transient elastography(TE); Procedure: Smart-Shear Wave(SSW) imaging

Study type: Observational

Funder types: Other

Identifiers

NCT02569567

2015-0782 (Other Identifier)

SMART15

Details and patient eligibility

About

The aim of this prospective study was to evaluate the applicability and diagnostic performances of Smart-Shear wave(SSW) imaging, in comparison with Transient elastography(TE) for the staging of liver fibrosis using pathologic results as the reference standard.

Enrollment: 105 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with liver disease: plan to undergo liver surgery
2. Potential liver donors
3. Smart-Shear wave & transient elastography were performed within one month from liver surgery
4. Aged between 20 to 80 years
5. Compliance with scheduled visits, evaluation plans and other study procedures

Exclusion criteria

1. Previous history of hepatic surgery
2. Previous history of transarterial chemoembolization
3. Huge or infiltrative tumor in the right lobe of the liver
4. Bile duct dilatation in the right lobe of the liver
5. Older than 80 years
6. The opinion of the investigator would make the patient unsuitable for enrollment

Trial design

105 participants in 1 patient group

US elastography

Description:

Participants who have the plan of liver transplantation or liver biopsy within 4 weeks will be screened from the outpatient clinic. Two types of ultrasonographic elastography(US elastography) techniques including Smart-Shear Wave(SSW) imaging and transient elastography(TE) will be performed as a diagnostic method for hepatic fibrosis.

Treatment:

Procedure: Smart-Shear Wave(SSW) imaging

Procedure: Transient elastography(TE)