ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
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|ClinicalTrials.gov Identifier: NCT02313649|
Recruitment Status : Completed
First Posted : December 10, 2014
Last Update Posted : April 19, 2016
|Condition or disease|
Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique.
ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis.
This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard).
The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed.
Liver stiffness measurement made by the Aixplorer will also be compared to blood markers
|Study Type :||Observational|
|Actual Enrollment :||447 participants|
|Official Title:||Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
- Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4). [ Time Frame: Within 12 months of the study start date ]This will be determined by histological examination of liver biopsy
- Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4). [ Time Frame: Within 12 months of the study start date ]This will be determined by histological examination of liver biopsy
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): NCT02313649
|People's Liberation Army General（301）Hospital|
|West China Hospital, Sichuan University|
|1st Affiliated Hospital, Sun Yat-Sen University|
|3rd Affiliated Hospital, Sun Yat-Sen University|
|GuangZhou 8th People's Hospital|
|1st Affiliated Hospital, Haerbin Medical University|
|1st Affiliated Hospital, ZheJiang University|
|YunNan Province Second People's Hospital|
|2nd Affiliated Hospital, Lanzhou University|
|Jiangsu Provincial Hospital|
|Shanghai 1st People's Hospital|
|Shengjing Hospital of Chinese Medical University|
|1st Affiliated Hospital, XiAn Transportation University|
|Isolation Hospital, HeNan Province|
|Principal Investigator:||Ping Liang||People's Liberation Army General（301）Hospital|