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

Isabel Graupera, Maja Thiele, for the LiverScreen Consortium Investigators, 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 HernándezJordi Hoyo, Matilde 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, Laurens van Kleef, Josep Lluis Falcó, Patrick S. Kamath, Tom H. Karlsen, Laurent Castera, Frank Lammert, Aleksander Krag, Pere Ginès

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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
Issue number1
DOIs
Publication statusPublished - 19 Jul 2022

Bibliographical note

Funding
This study is funded by the European Commission H20/20 program, under the call SC1-BHC-30-2019 named “Towards risk-based screening strategies for non-communicable diseases”, Project number: 847989. The funding body played no role in the design of the study, collection, analysis, and interpretation of data, nor in writing the manuscript.

PG and members of his group have been supported by AGAUR 2017SGR-01281. CIBEREHD (Centro de Investigacion Biomedica en Enfermedades Hepaticas y Digestivas), and PI18/01330- PI18/00662 – PI18/00862 from the Fundación de Investigación Sanitaria and cofunded by Instituto Carlos III (ISCIII)-Subdirección General de Evaluación and the European Regional Development Fund. Also supported in part by a grant from Gilead’s Investigator sponsored research program: study number IN-ES-989-5309.

Publisher Copyright: © 2022, The Author(s).

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