BACKGROUND: Patients with advanced chronic liver disease (ACLD) are at high risk of developing hepatocellular carcinoma (HCC). Therefore, biannual surveillance is recommended. This large-scale multicenter study aimed to stratify the risk of HCC development in ACLD. METHODS: From 3016 patients with ACLD screened in 17 European and Chinese centers, 2340 patients with liver stiffness measurement (LSM) determined using different techniques (two-dimensional shear-wave elastography [2D-SWE], transient elastography, and point shear-wave elastography) and with different disease severities were included. Cox regression was used to explore risk factors for HCC. We used these data to create an algorithm, named PLEASE, but referred to in this manuscript as "the algorithm"; the algorithm was validated in internal and two external cohorts across elastography techniques. RESULTS: HCC developed in 127 (5.4%) patients during follow-up. LSM by 2D-SWE (hazard ratio: 2.28) was found to be associated with developing HCC, alongside age, sex, etiology, and platelet count (C-index: 0.8428). We thus established the algorithm with applicable cutoffs, assigning a maximum of six points: platelet count less than 150×109/l, LSM greater than or equal to 15 kPa, age greater than or equal to 50 years, male sex, controlled/uncontrolled viral hepatitis, or presence of steatotic liver diseases. Within 2 years, with a median follow-up of 13.7 months, patients in the high-risk group (≥4 points) had an HCC incidence of 15.6% (95% confidence interval [CI], 12.1% to 18.7%) compared with the low-risk group, at 1.7% (95% CI, 0.9% to 2.5%). CONCLUSIONS: Our algorithm stratified patients into two groups: those at higher risk of developing HCC and those at lower risk. Our data provide equipoise to test the prospective utility of the algorithm with respect to clinical decisions about screening patients with ACLD for incident HCC. (Funded by the German Research Foundation and others; ClinicalTrials.gov number, NCT03389152.).

Angers University Hospital and HIFIH Lab University of Angers Angers France

Clinic for Radiology Faculty of Medicine Münster University Münster Germany

Department of Gastroenterology and Hepatology Odense University Hospital Odense Denmark

Department of Gastroenterology and Hepatology Section of Liver and Biliopancreatic Disorders University Hospitals Leuven Leuven Belgium

Department of Gastroenterology Hepatology Antwerp University Hospital Antwerp Belgium

Department of Hepato Gastroenterology Institute for Clinical and Experimental Medicine Prague Czech Republic

Department of Internal Medicine 1 Bonn University Hospital Bonn Germany

Department of Internal Medicine 1 Frankfurt University Hospital Frankfurt am Main Germany

Department of Internal Medicine B Faculty of Medicine University of Münster Münster Germany

Department of Internal Medicine University Hospital Knappschaftskrankenhaus Bochum Ruhr University Bochum Bochum Germany

Department of Radiology Beaujon Hospital Clichy France

Department of Ultrasound Zhongshan Hospital Fudan University Shanghai China

Division of Gastroenterology and Hepatology Department of Internal Medicine 3 Medical University of Vienna Vienna

Dubrava University Hospital University of Zagreb School of Medicine Zagreb Croatia

European Foundation for the Study of Chronic Liver Failure Barcelona

Fédération des Spécialités Digestives Edouard Herriot Hospital Lyon France

Gastroenterology and Hepatology Victor Babes University of Medicine and Pharmacy Timișoara Romania

Hepatology Department Cochin Hospital Paris Descartes University INSERM U 1223 Pasteur Institute Paris

Hepatology Unit University Hospital Bordeaux and INSERM U1053 University of Bordeaux Bordeaux France

InflaMed Centre of Excellence Translational Sciences in Inflammation and Immunology Laboratory of Experimental Medicine and Pediatrics Faculty of Medicine and Health Sciences Antwerp University Hospital Antwerp Belgium

University Clinic for Visceral Surgery and Medicine Bern University Hospital Department of Biomedical Research University of Bern Bern Switzerland

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ClinicalTrials.gov
NCT03389152