Comparison of Smart-Shear Wave Elastography and Transient Elastography

Fibrosis, Liver Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02569567
• Other study ID #: SMART15
• Secondary ID: 2015-0782
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2015
• Last updated: November 14, 2015
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2015
• Source: Asan Medical Center
• Contact: So Yeon Kim, Dr
• Phone: 82-2-3010-5980
• Email: sykim.radiology[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fibrosis
• Fibrosis, Liver

Intervention

Procedure:
• Smart-Shear Wave(SSW) imaging
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.
• Transient elastography(TE)
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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No