Liver Fibrosis Assessment Using Transient Elastography Guided with Real-Time B-mode Ultrasound Imaging: A Feasibility Study

Liver fibrosis is a kind of chronic damage of the liver and can lead to cirrhosis, one of the top 10 causes of death in the Western world. However, there is still a lack of noninvasive methods for diagnosing liver fibrosis. Fibroscan (Echosens, Paris, France), a device based on A-mode transient elastography, has shown promising results. In this study, a transient elastography system with real-time B-mode imaging for non-invasive liver fibrosis assessment, named Liverscan, was developed; its performance was tested and compared with that of the Fibroscan. A specific measurement probe was designed and fabricated with a B-mode ultrasound transducer fixed along the axis of a mechanical vibrator. It was integrated with the Liverscan to measure liver stiffness based on the shear wave propagation in liver tissues. The system was validated by mechanical indentation test using custom-made agar-gelatin phantoms with different stiffness. To further test its feasibility, in vivo measurements were conducted in 67 volunteers (age, 34 ± 3 years; body mass index, 21.3 ± 2.8 kg/m2; Mean ± SD., 34 male and 33 female), including 20 patients with various liver diseases, and 28 (19 male and 9 female) being tested by both Liverscan and Fibroscan. A significant linear correlation between the stiffness measured by the mechanical indentation test and that by the Liverscan (r = 0.973; p < 0.001) was obtained. The in vivo liver stiffness measured by Liverscan was also correlated with that by Fibroscan significantly (r = 0.886; p < 0.001). There was a significant difference in liver stiffness between the 20 patients and the other healthy subjects (14.1 ± 3.4 kPa vs. 10.5 ± 2.1 kPa; p = 0.001). The intra- and inter-observer tests indicated that the measurements were repeatable with intra-class correlation coefficients being 0.987 (p < 0.001) and 0.988 (p < 0.001), respectively. This study demonstrated that Liverscan with a specifically designed probe was able to measure and differentiate liver of different stiffness using the established measurement protocol under the guidance of real-time B-mode ultrasound imaging.