Comparison of Smart-Shear Wave Elastography and Transient Elastography
SMART
Applicability, Reliability and Accuracy for Staging Hepatic Fibrosis: Comparison of Smart-Shear Wave Elastography and Transient Elastography
2 other identifiers
observational
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedNovember 17, 2015
October 1, 2015
7 months
October 5, 2015
November 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Evaluation of diagnostic accuracy to predict the degree of hepatic fibrosis.
1 year
The correlation between two US elastography techniques
1 year
Reliability of Smart-Shear Wave(SSW) comparing diagnostic performance according to the reliable measurement index(RMI) results
1 year
Precision of Smart-Shear Wave(SSW)
1 year
Study Arms (1)
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.
Interventions
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.
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.
Eligibility Criteria
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%.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 05505, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
So Yeon Kim, Dr
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 7, 2015
Study Start
November 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
November 17, 2015
Record last verified: 2015-10