Data shows that liver cirrhosis accounts for 1.2 million deaths every year globally, making it the 12th most important cause of death. Close to the number due to TBC (1.3M) and AIDS (1.3M) and higher than other major disease like malaria (0.9M) or even for example colorectal and breast cancer together (1.2M). If deaths due to hepatocellular cancer would be taken into account, often caused by cirrhosis, liver cirrhosis would even be the fifth leading cause of death. With the current worldwide obesity ‘pandemic’ still not being slowed down, and the alcohol consumption in the world is progressively increasing, liver cirrhosis is becoming an even larger burden every year. Thus, there is a urgent need for a screening method to diagnosis cirrhosis in an early stage when it can still be put to a halt or treatment costs are low.

The primary objective of this project was to investigate the clinical and economic relevance of using TE technology in mass screening of liver fibrosis and cirrhosis. This project therefore used existing FibroScan models already developed and available on the market. To effectively diagnose early liver cirrhosis, in this project a method based on measuring liver stiffness by using TE was used. Previous studies have shown that liver stiffness correlates with liver fibrosis, the higher the stiffness the greater the amount of fibrosis in liver tissue. Among the different methods (e.g. acoustic radiation force impulse imaging, 2D shear wave elastography, and magnetic resonance elastography) available to measure liver stiffness, TE is the most validated and commonly used worldwide (see also competition section). Furthermore, TE is a user-friendly procedure, can be done quickly (<5 min) at the bedside or in the outpatient clinic by nurses or physician assistants with immediate results, and has a short learning curve. Several studies and meta-analyses have confirmed the excellent performance of TE for diagnosing cirrhosis in patients with chronic liver diseases, with a mean area under the receiver operating characteristic curve (AUROC) value of 0·94 and a suggested optimal cut-off of 13 kPa.

Because of its excellent performance, its wide availability and its inocuity, TE is recommended by international guidelines as the first-line approach to prioritise treatment for patients with HCV or HIV–HCV co-infection, on the basis of disease stage. TE currently is the reference non-invasive technology for the management of patients with chronic liver diseases, supported by both clinical publications and internationally recognized guidelines. With over 1,500 peer reviewed clinical publications worldwide, this has demonstrated the relevance of using TE in a variety of liver etiologies, diseases stages and settings, led to robust cut-off values used every day by physicians in their clinical practice and recommended in the guidelines of prominent health and clinical organizations worldwide (e.g. World Health Organizations (WHO), the European Association for the Study of the Liver (EASL), the American Association for the Study of Liver Diseases (AASLD) and the Asian Pacific Association for the Study of the Liver (APASL).