The results of the study are good news for chronic hepatitis B and C sufferers who now often undergo repeated and potentially painful liver biopsies as part of their disease management.
The focus of the research was the French-made FibroScan, which was being used in more than 70 countries worldwide when it received approval by the U.S. Food and Drug Administration in April.
The study was presented at the annual meeting of the American Association for the Study of Liver Diseases being held in Washington, DC, Nov. 1-5.
In liver biopsy, a sample of tissue is most often collected using a needle inserted through the skin and underlying tissue and into the liver. It is widely regarded as safe, but because it's invasive, carries risks ranging from pain and bleeding, to rare instances of death.
FibroScan replaces liver biopsies with a quick and painless procedure similar to the familiar ultrasound tests long used to diagnose and track pregnancy, as well as internal disease.
It's based on a technology called transient elastography, which measures liver "stiffness" to assess the degree of fibrosis - scarring - and guide ongoing treatment. The scan is performed as an outpatient procedure, taking only about 15 minutes, and providing immediate results on the degree of liver fibrosis.
To confirm the accuracy of FibroScan - already established by research studies in Europe and Asia - the new U.S. research focused on 814 patients with chronic type B and C viral hepatitis.
Each was examined using FibroScan followed by liver biopsy, and the results were compared according to several criteria.
"What we found," said Stuart C. Gordon, M.D., director of the Hepatology section at Henry Ford, who participated in the study, "confirms that FibroScan very accurately assesses for the presence of cirrhosis in patients with both types of chronic viral hepatitis."
The study also noted that the device "exhibits excellent reproducibility," which makes it a "reasonable alternative" to liver biopsy.