Ultrasonography SWE for Hepatic Fibrosis Evaluation

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673411
• Other study ID #: SNUH-2016-0065
• Status: Completed
• Start date: March 3, 2016
• Est. completion date: January 16, 2017

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 16, 2017
• Est. primary completion date: September 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis

Intervention

Device:
• ultrasound shear wave elastography
ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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