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Ultrasonography SWE for Hepatic Fibrosis Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673411
Recruitment Status : Unknown
Verified October 2016 by Jeong Min Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Jeong Min Lee, 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.

Condition or disease Intervention/treatment
Cirrhosis 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.

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Study Type : Observational
Estimated Enrollment : 158 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Diagnostic Performance of Shear Wave Elastography for Fibrosis Evaluation: Preliminary Study
Study Start Date : March 2016
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Device: ultrasound shear wave elastography
    ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography.
    Other Name: GE LOGIQ E9


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673411


Contacts
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Contact: Hyun Hee Lee, RN 82-2-2072-4177 redlion55@naver.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun Hee Lee, RN    82-2-2072-4177    redlion55@naver.com   
Contact: Jeong Hee Yoon, MD    82-2-2072-2293    jhjhry@gmail.com   
Principal Investigator: Jeong Min Lee, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital
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Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02673411    
Other Study ID Numbers: SNUH-2016-0065
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeong Min Lee, Seoul National University Hospital:
elastography
ultrasonography
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes