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

Tytuł:: LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries.
Autorzy:: Graupera I; Liver Unit Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain.; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.; Centro de Investigación En Red de Enfermedades Hepáticas Y Digestivas (Ciberehd), Barcelona, Spain.; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.
Thiele M; Centre for Liver Research, Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute for Clinical Research, University of Southern Denmark Odense, Odense, Denmark.
Ma AT; Liver Unit Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain.; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.
Serra-Burriel M; Epidemiology, Statistics, and Prevention Institute, University of Zurich, Zurich, Switzerland.
Pich J; Clinical Trial Unit, Hospital Clínic, 08036, Barcelona, Spain.
Fabrellas N; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.
Caballeria L; Unitat de Suport a la Recerca Metropolitana Nord, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Metropolitana Nord, IDIAP Jordi Gol, ICS Institut Català de la Salut, Barcelona, Spain.
de Knegt RJ; Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, the Netherlands.
Grgurevic I; Department of Gastroenterology, Hepatology and Clinical Nutrition, University Hospital Dubrava, University of Zagreb School of Medicine and Faculty of Pharmacy and Biochemistry, Zagreb, Croatia.
Reichert M; Department of Medicine II, Saarland University Medical Center, Homburg, Germany.
Roulot D; Unité d'Hépatologie, Hôpital Avicenne, AP-HP, Université Paris 13, Bobigny, France.
Schattenberg JM; Metabolic Liver Research Program, Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg, Mainz, Germany.
Pericas JM; Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d´Hebron, Vall d'Hebron Institut de Recerca (VHIR) , Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.; Universitat Autònoma de Barcelona, Barcelona, Spain.
Angeli P; Unit of Internal Medicine and Hepatology (UIMH), Department of Medicine (DIMED), University-Teaching Hospital of Padova, Padua, Italy.
Tsochatzis EA; UCL Institute for Liver and Digestive Health, Royal Free Hospital, University College of London (UCL), London, UK.
Guha IN; NIHR Nottingham Biomedical Research University Mainz Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK.
Garcia-Retortillo M; Liver Section, Gastroenterology Department, Hospital del Mar, Department of Medicine, IMIM, Barcelona, Spain.
Morillas RM; Liver Unit, Hospital Germans Trias i Pujol, IGTP, Badalona, Spain.
Hernández R; Institut Catala de la Salut (ICS). BCN. Ambit d'Atencio Primaria, Barcelona, Spain.
Hoyo J; Institut Catala de la Salut (ICS). BCN. Ambit d'Atencio Primaria, Barcelona, Spain.
Fuentes M; Institut Catala de la Salut (ICS). BCN. Ambit d'Atencio Primaria, Barcelona, Spain.
Madir A; Department of Gastroenterology, Hepatology and Clinical Nutrition, University Hospital Dubrava, University of Zagreb School of Medicine and Faculty of Pharmacy and Biochemistry, Zagreb, Croatia.
Juanola A; Liver Unit Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain.; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.; Centro de Investigación En Red de Enfermedades Hepáticas Y Digestivas (Ciberehd), Barcelona, Spain.; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.
Soria A; Liver Unit Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain.; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.
Juan M; Clinical Trial Unit, Hospital Clínic, 08036, Barcelona, Spain.
Carol M; Liver Unit Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain.; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.; Centro de Investigación En Red de Enfermedades Hepáticas Y Digestivas (Ciberehd), Barcelona, Spain.; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain.
Diaz A; Department of Pathology. Centre of Biomedical Diagnosis. Hospital Cínic, Barcelona, Spain.
Detlefsen S; Department of Pathology, Odense University Hospital (OUH), University of Southern Denmark, Odense, Denmark.
Toran P; Unitat de Suport a la Recerca Metropolitana Nord, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Metropolitana Nord, IDIAP Jordi Gol, ICS Institut Català de la Salut, Barcelona, Spain.
Pera G; Unitat de Suport a la Recerca Metropolitana Nord, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Metropolitana Nord, IDIAP Jordi Gol, ICS Institut Català de la Salut, Barcelona, Spain.
Fournier C; Echosens, Paris, France.
Llorca A; Echosens, Paris, France.
Newsome PN; National Institute for Health Research Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, Birmingham, UK.
Manns M; Health Sciences, Hannover Medical School MHH, Hannover, Germany.
de Koning HJ; Department of Public Health, Erasmus University Medical Center, Rotterdam, the Netherlands.
Serra-Burriel F; Barcelona Super Computing Center (BSC), Barcelona, Spain.
Cucchietti F; Barcelona Super Computing Center (BSC), Barcelona, Spain.
Arslanow A; Liver Unit Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain.; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.; Metabolic Liver Research Program, Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg, Mainz, Germany.
Korenjak M; European Liver Patients' Association, Brussels, Belgium.
van Kleef L; Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, the Netherlands.
Falcó JL; Genesis Biomed, Barcelona, Spain.
Kamath PS; Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA.
Karlsen TH; Oslo University hospital, Oslo, Norway.
Castera L; Department of Hepatology, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Clichy, Université de Paris, Paris, France.
Lammert F; Department of Medicine II, Saarland University Medical Center, Homburg, Germany.; Institute for Occupational Medicine and Public Health, Saarland University, Homburg, Germany.; Hannover Medical School (MHH), Hannover, Germany.
Krag A; Centre for Liver Research, Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute for Clinical Research, University of Southern Denmark Odense, Odense, Denmark.
Ginès P; Liver Unit Hospital Clínic, University of Barcelona, Barcelona, Catalonia, Spain. .; Institut D'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. .; Centro de Investigación En Red de Enfermedades Hepáticas Y Digestivas (Ciberehd), Barcelona, Spain. .; Faculty of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain. .
Corporate Authors:: LiverScreen Consortium investigators
Źródło:: BMC public health [BMC Public Health] 2022 Jul 19; Vol. 22 (1), pp. 1385. Date of Electronic Publication: 2022 Jul 19.
Typ publikacji:: Clinical Study; Journal Article; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: London : BioMed Central, [2001-
MeSH Terms:: Elasticity Imaging Techniques*/methods
Liver Cirrhosis*/diagnostic imaging
Liver Cirrhosis*/pathology
Mass Screening*/methods
Biopsy ; Europe ; Humans
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Contributed Indexing:: Investigator: M Alvarez; P Andersen; P Angeli; A Ardèvol; A Arslanow; L Beggiato; ZB Abdesselam; L Bennett; B Boutouria; A Brocca; MT Broquetas; L Caballeria; V Calvino; J Camacho; A Capdevila; M Carol; L Castera; M Cervera; F Cucchietti; A de Fuentes; R de Knegt; S Detlefsen; A Diaz; JD Bande; V Esnault; N Fabrellas; JL Falco; R Fernández; C Fournier; M Fuentes; P Galle; E García; M García-Retortillo; E Garrido; P Ginès; RG Medina; J Gratacós-Gines; I Graupera; I Grgurevic; IN Guha; E Guix; R Harris; EH Boluda; R Hernández-Ibañez; J Hoyo; A Ikram; S Incicco; M Israelsen; M Juan; A Juanola; R Kaiser; PS Kamath; TH Karlsen; M Kjærgaard; HJ de Koning; M Korenjak; A Krag; JK Hansen; M Krawczyk; I Lambert; F Lammert; P Laboulaye; SL Sørensen; C Laserna-Jiménez; SL Pi; E Ledain; V Levy; V Londoño; G Loyer; A Llorca; AT Ma; A Madir; M Manns; D Marshall; ML Martí; S Martínez; RM Sala; RM Font; JM Jensen; RM Morillas; L Muñoz; R Nadal; L Napoleone; JM Navarrete; PN Newsome; V Nielsen; M Pérez; JMP Pulido; S Piano; J Pich; JP Escobet; E Pose; KP Lindvig; M Reichert; C Riba; D Roulot; AB Rubio; M Sánchez-Morata; J Schattenberg; F Serra-Burriel; M Serra-Burriel; LS Just; M Sonneveld; A Soria; C Stern; P Such; M Thiele; P Toran; A Torrejón; M Tonon; EA Tsochatzis; L van Kleef; P van Wijngaarden; V Velázquez; A Viu; SN Weber; T Wildsmith
Keywords: Chronic liver disease; Cirrhosis; Liver fibrosis; NAFLD; NASH; Screening; Vibration-controlled transient elastography
Molecular Sequence:: ClinicalTrials.gov NCT03789825
Entry Date(s):: Date Created: 20220719 Date Completed: 20220721 Latest Revision: 20230522
Update Code:: 20240104
PubMed Central ID:: PMC9295430
DOI:: 10.1186/s12889-022-13724-6
PMID:: 35854275
: Czasopismo naukowe

Pełny tekst

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 ).
(© 2022. The Author(s).)

Erratum in: BMC Public Health. 2023 May 22;23(1):923. (PMID: 37217864)

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