Ultrasonography SWE for Hepatic Fibrosis Evaluation

Completed

• Conditions: Cirrhosis

• Registration Number: NCT02673411
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-03
• Study Start: 2016-03-03
• Primary Completion: 2016-09-27
• Study Completion: 2017-01-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Read More

Exclusion Criteria

• none

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of