Ultrasonography SWE for Hepatic Fibrosis Evaluation

Diagnostic Performance of Shear Wave Elastography for Fibrosis Evaluation: Preliminary Study

The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Device: ultrasound shear wave elastography

Detailed Description

Hepatic fibrosis causes liver dysfunction and HCC. Since hepatic fibrosis is reversible dynamic condition, its monitoring is important to predict long term outcome and to determine treatment plan.

The reference of standard to diagnose hepatic fibrosis is biopsy, but recently non-invasive method such as stiffness imaging has been drawing a lot of attention. In this study, ultrasound shear wave elastography will be performed and its diagnostic performance to detect advanced hepatic fibrosis (= > F2) will be measured using histologic grade as a reference.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled to undergo liver resection or liver biopsy (n=138). Volunteers who agree to undergo US shear wave elastography (n=20) to determine inter-observer agreement.

Description

Inclusion Criteria:

• volunteers who agree to undergo US shear elastography OR
• patients with chronic liver disease who are scheduled to undergo liver resection or liver parenchymal biopsy.

AND

• = or > 18 years
• sign informed consent

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic performance to detect advanced hepatic fibrosis	from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interobserver agreement of ultrasound SWE	two observers perform ultrasound SWE on the same day in volunteers.	1 day
agreement with MR elastography	interval between US and MR elastography in patients with available MR elastography	1 month
Technical success rate	technical success or failure of US elastography using GE LOGIQ E9 scanner in ALL study population	6 months
Reliable measurement rate	reliable measurement rate (interquartile range of serial measurement/median LS value <30%) in patients with technically successful US elastography	6 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2016
• Primary Completion (Actual): September 27, 2016
• Study Completion (Actual): January 16, 2017

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: ultrasonography; elastography
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: SNUH-2016-0065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO