Advertisement

Topics

FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy

2014-07-24 14:29:18 | BioPortfolio

Summary

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.

Description

STUDY OBJECTIVES:

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).

STUDY DESIGN:

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.

Study Sites:

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.

Study Population:

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.

Sample Size:

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Cirrhosis

Intervention

FibroScan

Location

BIDMC
Boston
Massachusetts
United States
02215

Status

Recruiting

Source

Beth Israel Deaconess Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:29:18-0400

Clinical Trials [283 Associated Clinical Trials listed on BioPortfolio]

Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis

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...

FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease

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...

Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan by Fibroscan

Compare the Fibroscan results of preeclamptic women to normal controls and to find out if the changes are reversible after labor. Materials and Methods

Fibroscan® and Its Dedicated Probes Efficiency in Obese Patients

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...

Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients

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...

PubMed Articles [492 Associated PubMed Articles listed on BioPortfolio]

Comparison of laboratory tests, ultrasound, or MRE to detect fibrosis in patients with non-alcoholic fatty liver disease: A meta-analysis.

Many noninvasive methods for diagnosing liver fibrosis (LF) have been proposed. To determine the best method for diagnosing LF in nonalcoholic fatty liver disease (NAFLD), we conducted a systemic revi...

A prospective comparative assessment of the accuracy of the FibroScan in evaluating liver steatosis.

Recent studies have demonstrated the utility of the FibroScan® device in diagnosing liver steatosis, but its usefulness has not been thoroughly appraised. We investigated the usefulness of the contro...

Controlled Attenuation Parameter (CAP) with the XL Probe of the Fibroscan(®): A Comparative Study with the M Probe and Liver Biopsy.

Controlled attenuation parameter (CAP) is a new method for the diagnosis of steatosis. Until now, CAP was available only with the M probe of the Fibroscan. The aim of this study was to evaluate the di...

Outcome of in- and out-of-hospital cardiac arrest survivors with liver cirrhosis.

Organ failure increases mortality in patients with liver cirrhosis. Data about resuscitated cardiac arrest patients with liver cirrhosis are missing. This study aims to assess aetiology, survival and ...

Statin use and virus-related cirrhosis: A systemic review and meta-analysis.

Liver cirrhosis and its complications are important factors contributing to mortality worldwide. Statin use is probably associated with lower risk of hepatic decompensation and mortality, but not with...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy"

Quick Search
Advertisement
 

Relevant Topic

Hepatology
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...