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.
Study Type
OBSERVATIONAL
Enrollment
105
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.
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.
Asan Medical Center
Seoul, South Korea
RECRUITINGNon-inferiority of Smart-Shear Wave(SSW) imaging compared to Transient elastography(TE) in diagnosis for hepatic fibrosis.
Applicability rate between Smart-Shear Wave(SSW) and Transient elastography(TE) will be compared to prove non-inferiority. Applicability rate = {\[Total cases- (failure cases + non-reliable measurement cases)\]/total case} \* 100 (%)
Time frame: 1 year
Evaluation of diagnostic accuracy to predict the degree of hepatic fibrosis.
Areas under the receiver operating curve (AUROCs) of the two techniques will be compared to estimate the probability of correctly predicting the degree of hepatic fibrosis. Substantial discordance between US elastography techniques and histologic staging will also be explored. It is defined as a difference in fibrosis stage by at least 2 points.
Time frame: 1 year
The correlation between two US elastography techniques
The correlation between the two US elastography techniques will be tested using the Spearman's correlation coefficient.
Time frame: 1 year
Reliability of Smart-Shear Wave(SSW) comparing diagnostic performance according to the reliable measurement index(RMI) results
Reliable measurement index (RMI) is an reliability index that computes the reliability of the calculated stiffness by analyzing the changes in shapes of propagated shear waves. The diagnostic performance of Smart-Shear wave will be assessed by comparing the RMI result.
Time frame: 1 year
Precision of Smart-Shear Wave(SSW)
Precision of Smart-Shear Wave(SSW) will be assessed using the composite factors, including intraclass correlation coefficients (ICCs), within subject SD(wSD), repeatability coefficient(RC), and within subject CV(wCV).
Time frame: 1 year
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