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 (Medlem af forfattergruppering), Maria Kjærgaard (Medlem af forfattergruppering), Johanne Kragh Hansen (Medlem af forfattergruppering), Jane Møller Jensen (Medlem af forfattergruppering), Vibeke Nielsen (Medlem af forfattergruppering), Katrine Prier Lindvig (Medlem af forfattergruppering), Louise Skovborg Just (Medlem af forfattergruppering)

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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).

OriginalsprogEngelsk
Artikelnummer1385
TidsskriftBMC Public Health
Vol/bind22
Antal sider10
ISSN1471-2458
DOI
StatusUdgivet - 19. jul. 2022

Bibliografisk note

Funding Information:
* Supported by the LiverScreen Consortium and funded by the European Commission under the program H20/20 to investigate screening for liver fibrosis and its applicability in European countries ( www.liverscreen.eu ).

Funding Information:
LC: Consultancy for Allergan, Alexion, Echosens, Gilead, Intercept, MSD, Novo Nordisk, and Pfizer. Speaker bureau for Abbvie, Echosens, Gilead, Intercept, and Novo Nordisk. Research grant from Gilead.

Funding Information:
RJK has received Investigator Initiated Research funding from: Gilead, has worked on advisory boards for: AbbVie, BMS, Gilead, Merck, has spoken for AbbVie, Echosens, Gilead, Philips.

Funding Information:
The LiverScreen Consortium includes: Marifé Alvarez, Peter Andersen, Paolo Angeli, Alba Ardèvol, Anita Arslanow, Luca Beggiato, Zahia Ben Abdesselam, Lucy Bennett, Bajiha Boutouria , Alessandra Brocca, M Teresa Broquetas, Llorenc Caballeria, Valeria Calvino, Judith Camacho, Aura Capdevila, Marta Carol, Laurent Castera, Marta Cervera, Fernando Cucchietti, Anna de Fuentes, Rob de Knegt, Sonke Detlefsen, Alba Diaz, José Diéguez Bande, Vanessa Esnault, Núria Fabrellas, Josep lluis Falco, Rosa Fernández, Celine Fournier, Matilde Fuentes, Peter Galle, Edgar García, Montserrat García-Retortillo, Esther Garrido, Pere Ginès, Rosa Gordillo Medina, Jordi Gratacós-Gines, Isabel Graupera, Ivica Grgurevic, Indra Neil Guha, Eva Guix, Rebecca Harris, Elena Hernández Boluda, Rosario Hernández-Ibañez, Jordi Hoyo, Arfan Ikram, Simone Incicco, Mads Israelsen, Marta Juan, Adria Juanola, Ralf Kaiser, Patrick S Kamath, Tom H Karlsen, Maria Kjærgaard, Harry J de Koning, Marko Korenjak, Aleksander Krag, Johanne Kragh Hansen, Marcin Krawczyk, Irina Lambert, Frank Lammert, Philippe Laboulaye, Simon Langkjær Sørensen, Cristina Laserna-Jiménez, Sonia Lazaro Pi, Elsa Ledain, Vincent Levy, Vanessa Londoño, Guirec Loyer, Anne Llorca, Ann T. Ma, Anita Madir, Michael Manns, Denise Marshall, M. Lluïsa Martí, Sara Martínez, Ricard Martínez Sala, Roser Masa Font, Jane Møller Jensen, Rosa M Morillas, Laura Muñoz, Ruth Nadal, Laura Napoleone, JM Navarrete, Phillip N Newsome, Vibeke Nielsen, Martina Pérez, Juan Manuel Pericas Pulido, Salvatore Piano, Judit Pich, Judit Presas Escobet, Elisa Pose, Katrine Prier Lindvig, Matthias Reichert, Carlota Riba, Dominique Roulot, Ana Belén Rubio, Maria Sánchez-Morata, Jörn Schattenberg, Feliu Serra-Burriel, Miquel Serra-Burriel, Louise Skovborg Just, Milan Sonneveld, Anna Soria, Christiane Stern, Patricia Such, Maja Thiele, Pere Toran, Antoni Torrejón, Marta Tonon, Emmanuel A Tsochatzis, Laurens van Kleef, Paulien van Wijngaarden, Vanessa Velázquez, Ana Viu, Susanne Nicole Weber, Tracey Wildsmith We acknowledge the help of Nicki van Berckel and Beatriz Márquez in the preparation of the manuscript.

Funding Information:
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.

Funding Information:
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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