Comparison of Smart-Shear Wave Elastography and Transient Elastography (SMART)

November 14, 2015 updated by: So Yeon Kim, Asan Medical Center

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 105 participants will be enrolled. Participants are patients with liver disease who are planning to undergo liver surgery, and potential liver donors for living related liver transplantation.

Study population size was calculated by considering a power of 80%(1-sided alpha of 25%), and an expected dropout rate of 10%.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
US elastography

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
  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.
Other Names:
  • S-Shearwave
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.
Other Names:
  • FibroScan®

What is the study measuring?

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.
Time Frame: 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 (%)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of diagnostic accuracy to predict the degree of hepatic fibrosis.
Time Frame: 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.
1 year
The correlation between two US elastography techniques
Time Frame: 1 year
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
Time Frame: 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.
1 year
Precision of Smart-Shear Wave(SSW)
Time Frame: 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).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: So Yeon Kim, Dr, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART15
  • 2015-0782 (Other Identifier: Asan Medical Center Institution Review Board(IRB))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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