Ultrasonography SWE for Hepatic Fibrosis Evaluation

NCT ID: NCT02673411

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-03

Study Completion Date

2017-01-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Cirrhosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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ultrasound shear wave elastography

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

Intervention Type DEVICE

Other Intervention Names

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GE LOGIQ E9

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-2016-0065

Identifier Type: -

Identifier Source: org_study_id

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