None listed
Conditions
Brief summary
Chronic hepatitis B virus infection(HBV) affects 400 million people worldwide. It leads to 1.2 million deaths annually. An individual's prognosis when affected by the disease is related to it's severity.Patients who have cirrhosis as a result of HBV have high rates of complications such as liver cancer and gastrointestinal bleeding.Patients with advancing disease therefore have a more compelling need for treatment ,thus accurate evaluation is essential. Liver biopsy up until now has been the gold standard for evaluation but it has many complications(incuding bleeding and death),contraindications and error .It is not suitable for serial assessment. A new device that has been developed in this regard is fibroscan.Fibroscan measures liver stiffness which equates to liver fibrosis(disease). It does this by transmitting a wave impulse through the liver.The faster the wave travels the more fibrosed the liver is.It is a non-invasive and painless procedure much like an ultrasound. Blood markers to assess liver fibrosis are also available but have not been well evaluated in patients with HBV. We propose to recruit 250 participants with chronic HBV from several Melbourne hopitals who are undergoing liver biopsy as part of their routine care.Participants will be required to fill in a detailed questionnaire in order to evaluate further their liver disease .Within 4 weeks of the biopsy a fibroscan will be performed along with blood tests helping to assess the degree of liver fibrosis. We willl compare the results of these non-invasive tests with liver biopsy results to review the diagnostic accuracy of fibroscan and blood fibrosis markers. We will also follow the participants for 2 years with annual fibroscans and blood tests to estimate progression of fibrosis and the affects of anti-viral medication on fibrosis.We also hope to assess the role of insensitivity to the body's natural insulin production to progression of liver fibrosis in patients with HBV by simply measuring fasting blood insulin and glucose levels and comparing these to the liver biopsy results.Insulin insensitivity has been confimed as an independent risk factor for liver fibrosis in a previous study of Hepatitis C patients,this has not yet been shown in a Hepatitis B population.
Interventions
All participants recruited in the study will have had a liver biopsy as part of their routine standard of care in the past 3 months. Liver biopsy is considered the gold standard in determining the stage of liver disease.Transient elastography and a serum fibrosis marker(hepascore) will be evaluated against biopsy results. Transient elastography(T.E)- liver stiffness which equates to liver fibrosis will be measured using T.E. T.E is an ultrasound like device which is placed over the liver and sen
All participants recruited in the study will have had a liver biopsy as part of their routine standard of care in the past 3 months. Liver biopsy is considered the gold standard in determining the stage of liver disease.Transient elastography and a serum fibrosis marker(hepascore) will be evaluated against biopsy results. Transient elastography(T.E)- liver stiffness which equates to liver fibrosis will be measured using T.E. T.E is an ultrasound like device which is placed over the liver and sends a vibration through the liver.The quicker the vibration passes through the liver the more fibrosed (or stiff) the liver is. It is a painless procedure lasting 10 minutes approximately.There are no associated adverse events.A total of 3 fibroscan sessions will take place on each patient.The first at baseline(within 4 weeks of liver biopsy) then at 12 months,then at 24months. Readings are measured in kilopascals. Blood samples will be taken first at baseline then at 12 months,then at 24months for hepascore, a serum fibrosis marker. Hepascore results will be correlated with liver biopsy result at baseline and then monitored over the 24 month period for alteration. According to best practice participants may be commenced on antiviral medications if indicated by their liver biopsy (standard of care). These oral medications will include tenofovir,lamivudine,entecavir and adefovir as is common practice. The decision to start medication and which medication to start will be in no way influenced by the study.At the 12 and 24 month period we compare fibroscan and serum fibrosis markers among the various medication groups(if any).
Sponsors
Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Chronic hepatitis B infection. Subjects having a liver biopsy as part of routine standard of clinical care. Body mass index < 36.
Exclusion criteria
Co-infection with Human Immunodeficiency Virus(HIV), HepatitisC Virus(HCV), or Hepatitis D Virus (HDV). Evidence of other causes of chronic liver disease. Decompensated liver disease including ascites. Evidence of alcohol abuse (> 20 gm/day) during the last 6 months. Anticipated or current use or need for significant concomitant medical treatment including but not limited to systemic immunosuppressive drugs, cytotoxics, or chemotherapeutic agents. History of recent acute hepatitis. Clinical or radiological suspicion of Hepatocellular Carcinoma(HCC). Presence of bleeding disorder. Presence of cardiac pacemaker. Contraindication to liver biopsy.
Outcome results
None listed