Health Problem: Approximately 3.2 million people in the United States have a chronic hepatitis C virus (HCV) infection, which puts them at risk for developing hepatic fibrosis or cirrhosis, a need for liver transplantation, and possible death due to liver failure or liver cancer. However, HCV infection is a treatable disease and effective antiviral treatments that can lead to undetectable levels of the virus are available. An accurate test to detect the early stages of an HCV infection-related complication, such as hepatic fibrosis, may lead to earlier treatment.
Technology Description: Ultrasound transient elastography (TE) is a noninvasive alternative or adjunct to liver biopsy and involves the analysis of ultrasonographic wave propagation and tissue deformation in patients suspected of having or known to have chronic liver disease. TE is based on the principle that fibrosis changes the elasticity and viscosity of tissue. By assessing the propagation of acoustic waves through the liver, which travel faster through fibrotic tissue, the presence and extent of fibrosis can be measured. This test can be performed in an ambulatory setting or at the bedside.
Controversy: Ultrasound TE is a physical method that may not be feasible or may have poor accuracy in patients who have conditions that interfere with ultrasonography, such as obesity, narrow spaces between the ribs, or an excessive accumulation of fat in the liver.
For the evaluation and management of adult patients with chronic HCV infection with known or suspected hepatic fibrosis:
- What is the accuracy of ultrasound TE relative to a reference standard of liver biopsy and histopathology for detecting and staging hepatic fibrosis?
- What is the accuracy of ultrasound TE compared with other technologies for detecting and staging hepatic fibrosis?
- What is the accuracy of ultrasound TE compared with other technologies for predicting progression of liver disease?
- Does the information provided by ultrasound TE improve treatment decisions and health outcomes?
- Is ultrasound TE associated with any safety issues?
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