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Hepatocyte apoptosis fragment product cytokeratin-18 M30 level and non-alcoholic steatohepatitis risk diagnosis: an international registry study

Zhang H 1 , Rios RS 2 , Boursier J 3 , Anty R 4 , Chan WK 5 , George J 6 Show all authors , Yilmaz Y 7 , Wong VW 8 , Fan J 9 , Dufour JF 10 , Papatheodoridis G 11 , Chen L 12 , Schattenberg JM 13 , Shi J 14 , Xu L 15 , Wong GL 8 , Lange NF 10 , Papatheodoridi M 11 , Mi Y 15 , Zhou Y 2 , Byrne CD 16 , Targher G 17 , Feng G 18 , Zheng M 2

Affiliations 

  • 1 Department of Biostatistics and Medical Record, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China
  • 2 Department of Hepatology, MAFLD Research Center, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, China
  • 3 Service d'Hépato-Gastroentérologie et Oncologie Digestive, Centre Hospitalier Universitaire d'Angers, Angers, France
  • 4 Université Côte d'Azur, CHU, INSERM, U1065, C3M, 06204 Nice, France
  • 5 Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 6 Storr Liver Centre, Westmead Institute for Medical Research, Westmead Hospital and University of Sydney, Sydney, NSW, Australia
  • 7 Department of Gastroenterology, School of Medicine, Marmara University, Istanbul, Turkey
  • 8 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong 999077, China
  • 9 Department of Gastroenterology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200000, China
  • 10 University Clinic for Visceral Surgery and Medicine, Inselspital, University Hospital Bern, Bern, Switzerland
  • 11 Academic Department of Gastroenterology, Medical School of National and Kapodistrian University of Athens, General Hospital, of Athens "Laiko", Athens, Greece
  • 12 Department of Gastroenterology, Ruijin Hospital, Shanghai 200000, China
  • 13 Metabolic Liver Research Program I, Department of Medicine, University Medical Center Mainz, Mainz, Germany
  • 14 The Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang 310000, China
  • 15 Tianjin Second People's Hospital, Tianjin 300000, China
  • 16 Southampton National Institute for Health and Care Research Biomedical Research Centre, University Hospital Southampton, Southampton General Hospital, Southampton, UK
  • 17 Section of Endocrinology, Diabetes and Metabolism, Department of Medicine, University and Azienda Ospedaliera Universitaria Integrata of Verona, Verona, Italy
  • 18 Xi'an Medical University, Xi'an, Shaanxi 710000, China
Chin Med J (Engl), 2023 Feb 05;136(3):341-350.
PMID: 36848175 DOI: 10.1097/CM9.0000000000002603

Abstract

BACKGROUND: Liver biopsy for the diagnosis of non-alcoholic steatohepatitis (NASH) is limited by its inherent invasiveness and possible sampling errors. Some studies have shown that cytokeratin-18 (CK-18) concentrations may be useful in diagnosing NASH, but results across studies have been inconsistent. We aimed to identify the utility of CK-18 M30 concentrations as an alternative to liver biopsy for non-invasive identification of NASH.

METHODS: Individual data were collected from 14 registry centers on patients with biopsy-proven non-alcoholic fatty liver disease (NAFLD), and in all patients, circulating CK-18 M30 levels were measured. Individuals with a NAFLD activity score (NAS) ≥5 with a score of ≥1 for each of steatosis, ballooning, and lobular inflammation were diagnosed as having definite NASH; individuals with a NAS ≤2 and no fibrosis were diagnosed as having non-alcoholic fatty liver (NAFL).

RESULTS: A total of 2571 participants were screened, and 1008 (153 with NAFL and 855 with NASH) were finally enrolled. Median CK-18 M30 levels were higher in patients with NASH than in those with NAFL (mean difference 177 U/L; standardized mean difference [SMD]: 0.87 [0.69-1.04]). There was an interaction between CK-18 M30 levels and serum alanine aminotransferase, body mass index (BMI), and hypertension ( P  

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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