LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries

Isabel Graupera, Maja Thiele, Ann T. Ma, Miquel Serra-Burriel, Judit Pich, Núria Fabrellas, Llorenç Caballeria, Robert J. de Knegt, Ivica Grgurevic, Mathias Reichert, Dominique Roulot, Jörn M. Schattenberg, Juan M. Pericas, Paolo Angeli, Emmanuel A. Tsochatzis, Indra Neil Guha, Montserrat Garcia-Retortillo, Rosa M. Morillas, Rosario Hernández, Jordi HoyoMatilde Fuentes, Anita Madir, Adrià Juanola, Anna Soria, Marta Juan, Marta Carol, Alba Diaz, Sönke Detlefsen, Pere Toran*, Céline Fournier, Anne Llorca, Phillip N. Newsome, Michael Manns, Harry J. de Koning, Feliu Serra-Burriel, Fernando Cucchietti, Anita Arslanow, Marko Korenjak, Aleksander Krag, for the LiverScreen Consortium investigators, Mads Israelsen (Member of author group), Maria Kjærgaard (Member of author group), Johanne Kragh Hansen (Member of author group), Jane Møller Jensen (Member of author group), Vibeke Nielsen (Member of author group), Katrine Prier Lindvig (Member of author group), Louise Skovborg Just (Member of author group)

*Corresponding author for this work

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Abstract

Background: The development of liver cirrhosis is usually an asymptomatic process until late stages when complications occur. The potential reversibility of the disease is dependent on early diagnosis of liver fibrosis and timely targeted treatment. Recently, the use of non-invasive tools has been suggested for screening of liver fibrosis, especially in subjects with risk factors for chronic liver disease. Nevertheless, large population-based studies with cost-effectiveness analyses are still lacking to support the widespread use of such tools. The aim of this study is to investigate whether non-invasive liver stiffness measurement in the general population is useful to identify subjects with asymptomatic, advanced chronic liver disease. Methods: This study aims to include 30,000 subjects from eight European countries. Subjects from the general population aged ≥ 40 years without known liver disease will be invited to participate in the study either through phone calls/letters or through their primary care center. In the first study visit, subjects will undergo bloodwork as well as hepatic fat quantification and liver stiffness measurement (LSM) by vibration-controlled transient elastography. If LSM is ≥ 8 kPa and/or if ALT levels are ≥1.5 x upper limit of normal, subjects will be referred to hospital for further evaluation and consideration of liver biopsy. The primary outcome is the percentage of subjects with LSM ≥ 8kPa. In addition, a health economic evaluation will be performed to assess the cost-effectiveness and budget impact of such an intervention. The project is funded by the European Commission H2020 program. Discussion: This study comes at an especially important time, as the burden of chronic liver diseases is expected to increase in the coming years. There is consequently an urgent need to change our current approach, from diagnosing the disease late when the impact of interventions may be limited to diagnosing the disease earlier, when the patient is asymptomatic and free of complications, and the disease potentially reversible. Ultimately, the LiverScreen study will serve as a basis from which diagnostic pathways can be developed and adapted to the specific socio-economic and healthcare conditions in each country. Trial registration: This study is registered on Clinicaltrials.gov (NCT03789825).

Original languageEnglish
Article number1385
JournalBMC Public Health
Volume22
Number of pages10
ISSN1471-2458
DOIs
Publication statusPublished - 19. Jul 2022

Keywords

  • Chronic liver disease
  • Cirrhosis
  • Liver fibrosis
  • NAFLD
  • NASH
  • Screening
  • Vibration-controlled transient elastography
  • Elasticity Imaging Techniques/methods
  • Liver Cirrhosis/diagnostic imaging
  • Europe
  • Humans
  • Biopsy
  • Mass Screening/methods

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