Fibrosis, LiverSMARTNCT02569567
Comparison of Smart-Shear Wave Elastography and Transient Elastography
An observational study of Fibrosis, Liver, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fibrosis, Liver
- What is being tested?
- Smart-Shear Wave(SSW) imaging and Transient elastography(TE)
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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%.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
So Yeon Kim, Dr, 82-2-3010-5980, sykim.radiology@gmail.com
About this study
Official title: 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.
- Conditions
- Fibrosis, Liver
- Being tested
- Smart-Shear Wave(SSW) imaging, Transient elastography(TE)
- Keywords
- Smart-Shear Wave(SSW), Transient Elastography(TE), Liver cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart-Shear Wave(SSW) imagingProcedure or surgery
Also called S-Shearwave
- 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)Procedure or surgery
Also called FibroScan®
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Smart-Shear Wave(SSW) imaging; Procedure: Transient elastography(TE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosis, LiverStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Asan Medical Center
- Investigators
- So Yeon Kim, Dr, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569567
- Sponsor's protocol ID
- SMART15
- Other IDs
- 2015-0782
- Acronym
- SMART
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability, Reliability and Accuracy for Staging Hepatic Fibrosis: Comparison of Smart-Shear Wave Elastography and Transient Elastography
- ClinicalTrials.gov ID
- NCT02569567
- Acronym / sponsor ID
- SMART / SMART15
- Conditions
- Fibrosis, Liver
- Keywords
- Smart-Shear Wave(SSW), Transient Elastography(TE), Liver cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US elastography | – | Procedure: Smart-Shear Wave(SSW) imaging, Procedure: 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart-Shear Wave(SSW) imagingAlso: S-Shearwave1. 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. | Procedure or surgery | US elastography |
| Transient elastography(TE)Also: FibroScan®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. | Procedure or surgery | US elastography |
Primary outcome
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 (%)
4 secondary outcomes
Evaluation of diagnostic accuracy to predict the degree of hepatic fibrosis.
Time frame: 1 year
The correlation between two US elastography techniques
Time frame: 1 year
Reliability of Smart-Shear Wave(SSW) comparing diagnostic performance according to the reliable measurement index(RMI) results
Time frame: 1 year
Precision of Smart-Shear Wave(SSW)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
So Yeon Kim, Dr principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrosis, Liver, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact So Yeon Kim, Dr (82-2-3010-5980, sykim.radiology@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of Smart-Shear Wave(SSW) imaging compared to Transient elastography(TE) in diagnosis for hepatic fibrosis. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.