Sonoelastography: Ultrasound Method to Measure Liver Fibrosis
|ClinicalTrials.gov Identifier: NCT01747772|
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease.
- To measure liver stiffness with sonoelastography in adults with suspect diffuse liver disease who will undergo non-focal liver biopsy as part of their routine clinical care
- To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis
- To evaluate the effect of steatosis and inflammation on the estimation of liver fibrosis using sonoelastography
|Condition or disease||Intervention/treatment||Phase|
|Chronic Liver Disease Non-Alcoholic Fatty Liver Disease Hepatitis C Virus (HCV) Coinfection Hepatitis B Virus (HBV) Drug-Induced Liver Injury||Device: Shear Wave Sonoelastography||Not Applicable|
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|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Biopsy specimens were assessed via Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) criteria by a pathologist who was blinded to the shear-wave elastography (SWE) values.|
|Official Title:||Evaluate the Utility of Shear Wave Sonoelastography as a Tool to Measure Liver Fibrosis Grade|
|Actual Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 14, 2014|
|Actual Study Completion Date :||February 14, 2014|
Experimental: Shear Wave Sonoelastography for Fibrosis Assessment
Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
Device: Shear Wave Sonoelastography
Shear Wave sonoelastography (SWE) as an ultrasound technique to measure liver fibrosis was performed on patients scheduled for non-focal liver biopsy. Results were compared with pathological score from liver biopsy.
Other Name: Supersonic Aixplorer
- Liver Elasticity Value Measured Using Sonoelastography (SE) [ Time Frame: Day 1 ]Liver elasticity/stiffness was assessed via SE and compared against results of liver biopsy as read by a single pathologist using the Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) 5-point scale (F [Fibrosis]0=no fibrosis, F1=portal fibrosis without septa, F2=portal fibrosis with few septa, F3=numerous septa without cirrhosis, and F4=cirrhosis). Using SE, fibrosis is measured in kilopascals (kPa) with normal values equaling approximately 5.5 kPa (normal liver stiffness ranges between 3.3-7.8 kPa). Significant Fibrosis (F3): = or > 7.6 kPa, Cirrhosis (F4): = or > 9.0- 26 kPa. A higher number corresponds to an increase in stiffness and hepatic fibrosis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747772
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Anthony E Samir, MD||Massachusetts General Hospital|