NASH

Determining the reliability of liver biopsies in NASH clinical studies

Liver biopsy sample evaluation is an essential part of clinical studies in nonalcoholic steatohepatitis (NASH) and is key in excluding confounding morbidities. Current scoring systems, which are decisive for study inclusion, rely on imprecisely defined histological features, leading to a high observer variability of disease categorization. In this News & Views, measures to overcome these limitations are discussed.

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References

  1. 1.

    Harrison, S. A. et al. Insulin sensitizer MSDC-0602K in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase IIb study. J. Hepatol. 72, 613–626 (2020).

    CAS  Article  Google Scholar 

  2. 2.

    Davison, B. A. et al. Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials. J. Hepatol. https://doi.org/10.1016/j.jhep.2020.06.025 (2020).

    Article  PubMed  Google Scholar 

  3. 3.

    Kleiner, D. E. et al. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology 41, 1313–1321 (2005).

    Article  Google Scholar 

  4. 4.

    The French METAVIR Cooperative Study Group. Intraobserver and interobserver variations in liver biopsy interpretation in patients with chronic hepatitis C. Hepatology 20, 15–20 (1994).

    Article  Google Scholar 

  5. 5.

    Bedossa, P. et al. Histopathological algorithm and scoring system for evaluation of liver lesions in morbidly obese patients. Hepatology 56, 1751–1759 (2012).

    Article  Google Scholar 

  6. 6.

    Caldwell, S. et al. Hepatocellular ballooning in NASH. J. Hepatol. 53, 719–723 (2010).

    Article  Google Scholar 

  7. 7.

    Crawford, A. R., Lin, X. Z. & Crawford, J. M. The normal adult human liver biopsy: a quantitative reference standard. Hepatology 28, 323–331 (1998).

    CAS  Article  Google Scholar 

  8. 8.

    European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatocellular carcinoma. J. Hepatol. 69, 182–236 (2018).

    Article  Google Scholar 

  9. 9.

    Bruix, J. & Sherman, M. Management of hepatocellular carcinoma: an update. Hepatology 53, 1020–1022 (2011).

    Article  Google Scholar 

  10. 10.

    Hallsworth, K. & Adams, L. A. Lifestyle modification in NAFLD/NASH: facts and figures. JHEP Rep. 1, 468–479 (2019).

    Article  Google Scholar 

Download references

Acknowledgements

The authors thank the members of the international liver pathology group the “Gnomes” for providing their invaluable input before drafting this article.

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Correspondence to Peter Schirmacher.

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Competing interests

P.S. and T.L. are involved in centralized liver biopsy evaluation in clinical studies (Dr. Falk Pharma GmbH).

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Longerich, T., Schirmacher, P. Determining the reliability of liver biopsies in NASH clinical studies. Nat Rev Gastroenterol Hepatol 17, 653–654 (2020). https://doi.org/10.1038/s41575-020-00363-8

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