NCT02569567

Comparison of Smart-Shear Wave Elastography and Transient Elastography

Applicability, Reliability and Accuracy for Staging Hepatic Fibrosis: Comparison of Smart-Shear Wave Elastography and Transient Elastography

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 105 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fibrosis, Liver

Interventions

Type	Name	Description
PROCEDURE	Smart-Shear Wave(SSW) imaging	1. All Smart-Shear Wave(SSW) imaging examinations will be performed by one operator. 2. The right lobe of the liver is examined through the intercostal view with the patient lying in a supine or semi-decubitus position with the right arm in maximal abduction. 3. Once the optimal sizes of the regions of interest is chosen, they are fixed for subsequent measurement in each subject. Special attention is paid to avoid any focal lesion, vessels, biliary tracts, or artifacts from nearby lung gas or cardiac movement.
PROCEDURE	Transient elastography(TE)	1. Using the M probe in patients with BMI \<30 kg/m2. 2. Liver measurement is taken at either the seventh or eighth intercostal space of each subject over the right lobe of the liver. The measuring depth ranges from 2.5 to 6.5 cm below the skin surface. 3. Examinations are performed by a sonographer blinded to S-shear wave elastography, and biological results.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-10-07
• Last updated: 2015-11-17

Locations

1 site across 1 country: South Korea