Role of Non-invasive test in detecting Fibrosis in chronic Hepatitis B

• Research type

  Research Study

• Full title

  Role of Non invasive tests (Methacetin Breath Test and Fibroscan) in detecting significant fibrosis in chronic Hepatitis B

• IRAS ID

  18749

• Sponsor organisation

  Kings College Hospital

• Eudract number

  2009-010808-28

• ISRCTN Number

  Not Known

• Research summary

  Hepatitis B virus infection predominantly affects the liver leading to long term inflammation and scarring. Liver blood tests are useful only to a certain extent in identifying patients with ongoing liver damage. Unfortunately they are not always reliable, since an individual suffering from chronic liver disease can have significant scarring and inflammation with near normal test results. The only reliable test that's considered a gold standard in recognising liver damage is a liver biopsy.Liver biopsy plays a crucial role in identifying individuals with significant inflammation and scarring who will benefit from treatment with medications (antiviral).However there are complications associated with liver biopsy like pain, bleeding and perforation of internal organs. Interpreting the biopsies are again quite challenging since it is dependent on the size of sample examined and even the same pathologist may provide slightly different scores of inflammation and scarring when the specimen is blindly reviewed at a later date.Because of these limitations several investigators have attempted to develop alternative methods by which to assess liver disease severity. One approach was the development of blood markers, which can estimate liver function. Such tests were developed by analyzing a battery of different blood markers or substances of inflammation and scarring. Unfortunately none of these tests were found to be in par with the liver biopsy.Breath test is a new concept, which could be utilized to assess the severity of liver disease. This test is performed by administering a compound called methacetin. The compound is metabolized (broken down) in the liver and one of the by-products is carbon dioxide called carbon 13, which will be lost in the patient??s breath. A normal functioning liver will breakdown a major amount of methacetin within a few hours, however this is not the case if there is ongoing inflammation or scarring. Hence, by measuring the amount and/or rate at which the metabolic product (C13) appears in the patient??s breath will provide a measure of liver function without the need for a liver biopsy in the future.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/34

• Date of REC Opinion

  21 Apr 2009

• REC opinion

  Favourable Opinion