Comparison of Smart-Shear Wave Elastography and Transient Elastography

• Conditions: Fibrosis, Liver
• Interventions: Procedure: Smart-Shear Wave(SSW) imaging; Procedure: Transient elastography(TE)

• Registration Number: NCT02569567
• Lead Sponsor: Asan Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Study Start: 2015-11
• Last Update Submitted: 2015-11-14
• Last Update Posted: 2015-11-17
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
US elastography	Smart-Shear Wave(SSW) imaging	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.
US elastography	Transient elastography(TE)	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.

Primary Outcome Measures

Name	Time	Method
Non-inferiority of Smart-Shear Wave(SSW) imaging compared to Transient elastography(TE) in diagnosis for hepatic fibrosis.	1 year	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 (%)

Secondary Outcome Measures

Name	Time	Method
The correlation between two US elastography techniques	1 year	The correlation between the two US elastography techniques will be tested using the Spearman's correlation coefficient.
Reliability of Smart-Shear Wave(SSW) comparing diagnostic performance according to the reliable measurement index(RMI) results	1 year	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.
Evaluation of diagnostic accuracy to predict the degree of hepatic fibrosis.	1 year	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.
Precision of Smart-Shear Wave(SSW)	1 year	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).

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of