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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
Sponsor:
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

Tracking Information
First Submitted Date February 1, 2016
First Posted Date February 3, 2016
Last Update Posted Date October 25, 2016
Study Start Date March 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2016)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 1, 2016)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrasonography SWE for Hepatic Fibrosis Evaluation
Official Title Diagnostic Performance of Shear Wave Elastography for Fibrosis Evaluation: Preliminary Study
Brief Summary The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Cirrhosis
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 1, 2016)
158
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02673411
Other Study ID Numbers SNUH-2016-0065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jeong Min Lee, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date October 2016