Ultrasonography SWE for Hepatic Fibrosis Evaluation
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|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
|Condition or disease||Intervention/treatment|
|Cirrhosis||Device: ultrasound shear wave elastography|
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 Type :||Observational|
|Estimated Enrollment :||158 participants|
|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|
- 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
- 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)
- interobserver agreement of ultrasound SWE [ Time Frame: 1 day ]two observers perform ultrasound SWE on the same day in volunteers.
- agreement with MR elastography [ Time Frame: 1 month ]interval between US and MR elastography in patients with available MR elastography
- Technical success rate [ Time Frame: 6 months ]technical success or failure of US elastography using GE LOGIQ E9 scanner in ALL study population
- 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
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
|Contact: Hyun Hee Lee, RNemail@example.com|
|Principal Investigator:||Jeong Min Lee, MD||Seoul National University Hospital|