Shearwave and Fibroscan elastography versus biopsy in hepatic fibrosis
Research type
Research Study
Full title
Comparison of Shear Wave elastography and Fibroscan elastography to hepatic biopsy in the diagnosis of hepatic fibrosis
IRAS ID
192800
Contact name
Edmund Godfrey
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Invasive liver biopsy remains the gold standard for assessment of liver fibrosis. Insults to the liver parenchyma result in a process of inflammation, scarring and fibrosis, on a spectrum from normal liver through mild, moderate and then severe fibrosis, and finally cirrhosis.
Traditionally, before the advent of ultrasound, liver biopsies were performed blindly, on the ward, by hepatologists, after percussing to find where the liver edge was felt to lie. Gradually, liver biopsies came to be almost exclusive carried out under ultrasound guidance, to ensure less morbidity; but morbidity persists, with severe bleeding occurring in approximately 1/400, and non-target organ injury, bile leak and pneumothorax are also know to occur. Death, though very rare, is also a recognized complication.
New non-invasive ultrasound based technologies have the potential for assessing presence and degree of liver fibrosis through imaging, thus circumventing the need for painful and potentially injurious biopsy. Fibroscan is an established elastographic measurement technology. A competing technology, Shear Wave, based on the same principle of hastened propagation of artificially induced waves through diseased liver parenchyma, has emerged. Both technologies are adaptations of conventional ultrasound, instead of listening for echoes from tissues, it relies on detecting the elasticity, or conversely the stiffness, of the liver it is interrogating.
Our aim is to assess the accuracy of the two sonographic methods compared to histologic examination of liver biopsy.
There are no excess risks in this study. Liver biopsy, which is ultrasound guided,with associated morbidity, was to be performed as it is clinically required. The two sonographic studies are adjuncts with no risks associated.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0298
Date of REC Opinion
25 Jul 2016
REC opinion
Favourable Opinion