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

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ClinicalTrials.gov Identifier: NCT02569567
Recruitment Status : Unknown
Verified October 2015 by So Yeon Kim, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : October 7, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, 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.

Condition or disease Intervention/treatment
Fibrosis, Liver Procedure: Smart-Shear Wave(SSW) imaging Procedure: Transient elastography(TE)

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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Applicability, Reliability and Accuracy for Staging Hepatic Fibrosis: Comparison of Smart-Shear Wave Elastography and Transient Elastography
Study Start Date : November 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: FibroScan®




Primary Outcome Measures :
  1. 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 (%)



Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569567


Contacts
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Contact: So Yeon Kim, Dr 82-2-3010-5980 sykim.radiology@gmail.com
Contact: So Hyun Park, Dr 82-2-3010-1497 nnoleeter@naver.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: So Yeon Kim, Dr    82-2-3010-5980    sykim.radiology@gmail.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: So Yeon Kim, Dr Asan Medical Center
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Responsible Party: So Yeon Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02569567    
Other Study ID Numbers: SMART15
2015-0782 ( Other Identifier: Asan Medical Center Institution Review Board(IRB) )
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: October 2015
Keywords provided by So Yeon Kim, Asan Medical Center:
Smart-Shear Wave(SSW)
Transient Elastography(TE)
Liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases