S-Shearwave Elastography for Assessment of Hepatic Fibrosis

June 27, 2018 updated by: Jeong Min Lee, Seoul National University Hospital

Diagnostic Performance of S-Shearwave Elastography for Hepatic Fibrosis Evaluation: a Multicenter Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

634

Phase

  • Not Applicable

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: S-Shearwave and TE
Diagnostic test: S-Shearwave and TE
S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance to detect severe hepatic fibrosis (F3)
Time Frame: 3 months
Reference standard: histologic diagnosis or Transient elastography
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes
Time Frame: 3 months
3 months
Intra-observer and inter-observer agreement of S-Shearwave measurements
Time Frame: same day
same day
Comparison of diagnostic performance: Shearwave vs. Transient elastography
Time Frame: 3 months
Reference standard: histologic diagnosis
3 months
Usefulness of auto-profile function in S-Shearwave measurements
Time Frame: 3 months
3 months
Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Samsung Medison

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 (ACTUAL)

May 22, 2017

Primary Completion (ACTUAL)

April 24, 2018

Study Completion (ACTUAL)

May 31, 2018

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ESTIMATE)

February 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2017-0215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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