Track topics on Twitter Track topics that are important to you
This study will examine the effectiveness of the FibroScan device in differentiating fibrosis in patients with hepatitis B and C. The FibroScan measures liver stiffness and will be correlated to the liver biopsy to see if it can diagnose the stage of liver disease. Patients who are scheduled to have a liver biopsy will also have a fibroscan and the stiffness will be correlated with the biopsy stage.
Co –Primary Aims:
- To diagnose cirrhosis in patients with chronic viral hepatitis B and C;
- To determine the correlation of the FibroScan measurement with Metavir liver fibrosis scores by differentiating no/mild fibrosis (F0-F1) from severe fibrosis (F2-F4).
This is a multi-center study in which the FibroScan measurements will be collected prospectively from patients with chronic hepatitis B and C virus presenting for liver biopsy. The study duration will be 12 months. The study will initially have 3 investigational sites in the United States. Up to 3 more investigational sites may be identified to participate in the trial.
Initially the following three sites will participate in the trial:
Duke University Medical Center, Durham, NC: Keyur Patel, M.D.; Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA: Nezam H. Afdhal, M.D.; St. Louis University, St. Louis, MO: Bruce R. Bacon M.D.
Subjects with chronic liver diseases secondary to chronic hepatitis C and hepatitis B, undergoing a liver biopsy as the standard of care for their disease, will be eligible for the study. Subjects with hepatitis C, co-infected with other infectious viral diseases, such as hepatitis B or HIV-1, or both, may also be candidates for study enrollment provided the inclusion/exclusion criteria are met.
The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least three (3) months. The time between the date of the FibroScan reading and the date of biopsy must not exceed six (6) months.
A total of 300 evaluable patients (males and females) will be enrolled in this study. Enrollment will be considered competitive allowing any one center to enroll up to 150 patients meeting study criteria to meet the goal of 300 subjects. Sample size is based on a prevalence of 20% cirrhosis.
Subject Inclusion Criteria:
- Subject is able to give informed consent for this study and agrees to provide a blood sample.
- Subject must be at least 18 years of age.
- Subject has had or will have a liver biopsy for chronic liver disease, secondary to HBV or HCV or within 6 months of FibroScan (experimental cohort 1 only).
- Subjects who have hepatitis C (HCV) or hepatitis B (HBV) should be treatment naïve or off interferon therapy or nucleoside/nucleotide analogs for HBV for a minimum of 3 months prior to the FibroScan and liver biopsy.
Subject Exclusion Criteria:
- Unable or unwilling to provide informed consent.
- Confirmed diagnosis and/or history of malignancy, or other terminal disease.
- Uninterpretable biopsy specimen.
- Missing critical clinical, biochemical and/or demographic information.
- Receiving anti-viral therapy for infection of HCV or HBV within 3 months prior to the FibroScan and liver biopsy.
- Subject with other chronic liver disease, including Wilson’s disease, alpha 1-antitrypsin deficiency, cholestatic liver disease, or hemochromatosis.
- Patient with clinical ascites
- Patients with morbid obesity defined as a body mass index (BMI) of greater than or equal to 40.
- Patients who are pregnant
- Patients who have an implantable cardiac device such as defibrillator or pacemaker
SAMPLE REQUIREMENTS and TESTING:
A minimum of 8 valid measurements will be obtained for each subject from the right lobe of the liver. The tip of the probe transducer will be covered with coupling gel and placed on the skin, between the ribs at the level of the right lobe of the liver. The operator, assisted by an ultrasonic time motion image, will locate a portion of the liver that is at least 4cm thick and free of large vascular structures. The depth of measurement will be between 25 mm and 65 mm. During the acquisition subjects will lie on their back with the right arm behind the head, in a similar position to that used for liver biopsy. The physician will take the measurements with the probe placed in the intercostal space. The median value of the estimates will be kept as the elasticity value of the liver for a given patient. The entire examination should last approximately 5 minutes.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Beth Israel Deaconess Medical Center
Published on BioPortfolio: 2014-07-24T14:29:18-0400
This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient e...
Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C. However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry) ar...
The main objective of the study is to evaluate the diagnostic performance of the XL probe for estimating degree of liver fibrosis/cirrhosis in obese patients > 28 kg/m² with various liver...
The purpose of this study is is to use non-invasive diagnostic tests, Fibroscan and a simple blood test, to diagnose NASH in patients who undergo liver transplantation. Liver transplantati...
This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessme...
FibroScan(®) is a tool for the noninvasive diagnosis of hepatic fibrosis. Previous studies have compared liver stiffness to percutaneous liver biopsy findings, but there were no studies which compare...
Hepatic encephalopathy (HE) is a serious complication of cirrhosis and is associated with gut dysbiosis. Proton pump inhibitors (PPIs), frequently prescribed to patients with cirrhosis, can contribute...
Liver cirrhosis is characterized by high morbidity and mortality rates. This study was addressed to evaluate the epidemiological and economic impact of cirrhosis on hospitalizations in a large populat...
Cirrhosis is a major risk factor for the development of hepatocellular carcinoma (HCC), but remains underdiagnosed in the compensated stage. Fibrosis progression and cirrhosis are associated with chan...
Current assessment of prognostic factors in cirrhosis patients with SIRS is not accurate. There are few reports in the literature, which makes it difficult to determine an indication for cirrhosis pat...
Experimentally induced chronic injuries to the parenchymal cells in the liver to achieve a model for LIVER CIRRHOSIS.
FIBROSIS of the hepatic parenchyma due to obstruction of BILE flow (CHOLESTASIS) in the intrahepatic or extrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC; BILE DUCTS, EXTRAHEPATIC). Primary biliary cirrhosis involves the destruction of small intra-hepatic bile ducts and bile secretion. Secondary biliary cirrhosis is produced by prolonged obstruction of large intrahepatic or extrahepatic bile ducts from a variety of causes.
FIBROSIS of the hepatic parenchyma due to chronic excess ALCOHOL DRINKING.
Abnormal increase of resistance to blood flow within the hepatic PORTAL SYSTEM, frequently seen in LIVER CIRRHOSIS and conditions with obstruction of the PORTAL VEIN.
Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...