Comparison of Smart-Shear Wave Elastography and Transient Elastography

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibrosis, Liver

Intervention / Treatment
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* Procedure: Smart-Shear Wave(SSW) imaging
* Procedure: Transient elastography(TE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with liver disease: plan to undergo liver surgery Potential liver donors Smart-Shear wave & transient elastography were performed within one month from liver surgery Aged between 20 to 80 years Compliance with scheduled visits, evaluation plans and other study procedures Exclusion Criteria: Previous history of hepatic surgery Previous history of transarterial chemoembolization Huge or infiltrative tumor in the right lobe of the liver Bile duct dilatation in the right lobe of the liver Older than 80 years The opinion of the investigator would make the patient unsuitable for enrollment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| US elastography<br>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. | Procedure: Smart-Shear Wave(SSW) imaging<br>* All Smart-Shear Wave(SSW) imaging examinations will be performed by one operator. 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. 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.<br>* Other names: S-Shearwave;Procedure: Transient elastography(TE)<br>* Using the M probe in patients with BMI <30 kg/m2. 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. Examinations are performed by a sonographer blinded to S-shear wave elastography, and biological results.<br>* Other names: FibroScan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-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 (%) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smart-Shear Wave(SSW), Transient Elastography(TE), Liver cirrhosis