Back to resultsS-Shearwave Elastography for Assessment of Hepatic Fibrosis
Primary Purpose
Liver Fibroses
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
S-Shearwave and TE
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Fibroses focused on measuring ultrasound elastography, S-Shearwave, liver, fibrosis
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers
- Signed informed consent
Exclusion Criteria:
- Acute hepatitis or bile duct obstruction
- Serum ALT> 5 times the upper limit of normal within 3 months
- s/p Rt. hemihepatectomy
- s/p liver transplantation
- Large mass or infiltrative lesion in the right lobe of the liver
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S-Shearwave and TE
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic performance to detect severe hepatic fibrosis (F3)
Reference standard: histologic diagnosis or Transient elastography
Secondary Outcome Measures
Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes
Intra-observer and inter-observer agreement of S-Shearwave measurements
Comparison of diagnostic performance: Shearwave vs. Transient elastography
Reference standard: histologic diagnosis
Usefulness of auto-profile function in S-Shearwave measurements
Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis
Full Information
NCT ID
NCT03047707
First Posted
February 8, 2017
Last Updated
June 27, 2018
Sponsor
Seoul National University Hospital
Collaborators
Samsung Medison
1. Study Identification
Unique Protocol Identification Number
NCT03047707
Brief Title
S-Shearwave Elastography for Assessment of Hepatic Fibrosis
Official Title
Diagnostic Performance of S-Shearwave Elastography for Hepatic Fibrosis Evaluation: a Multicenter Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Samsung Medison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibroses
Keywords
ultrasound elastography, S-Shearwave, liver, fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
634 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-Shearwave and TE
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
S-Shearwave and TE
Intervention Description
S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.
Primary Outcome Measure Information:
Title
Diagnostic performance to detect severe hepatic fibrosis (F3)
Description
Reference standard: histologic diagnosis or Transient elastography
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes
Time Frame
3 months
Title
Intra-observer and inter-observer agreement of S-Shearwave measurements
Time Frame
same day
Title
Comparison of diagnostic performance: Shearwave vs. Transient elastography
Description
Reference standard: histologic diagnosis
Time Frame
3 months
Title
Usefulness of auto-profile function in S-Shearwave measurements
Time Frame
3 months
Title
Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers
Signed informed consent
Exclusion Criteria:
Acute hepatitis or bile duct obstruction
Serum ALT> 5 times the upper limit of normal within 3 months
s/p Rt. hemihepatectomy
s/p liver transplantation
Large mass or infiltrative lesion in the right lobe of the liver
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
S-Shearwave Elastography for Assessment of Hepatic Fibrosis
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