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Completed

NCT Number: NCT02673411

Ultrasonography SWE for Hepatic Fibrosis Evaluation

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

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound shear wave elastography

Device

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

Other names: GE LOGIQ E9

Primary outcomes

  1. diagnostic performance to detect advanced hepatic fibrosis

    Time frame: 1 month

    from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis)

Secondary outcomes

  1. interobserver agreement of ultrasound SWE

    Time frame: 1 day

    two observers perform ultrasound SWE on the same day in volunteers.

  2. agreement with MR elastography

    Time frame: 1 month

    interval between US and MR elastography in patients with available MR elastography

  3. Technical success rate

    Time frame: 6 months

    technical success or failure of US elastography using GE LOGIQ E9 scanner in ALL study population

  4. Reliable measurement rate

    Time frame: 6 months

    reliable measurement rate (interquartile range of serial measurement/median LS value <30%) in patients with technically successful US elastography

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 3, 2016
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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