Reliability of Liver Biopsies in NASH Clinical Studies: What is Known So Far? What's Next?

Liver biopsy (LB) sample evaluation is an essential part of clinical studies in non-alcoholic steatohepatitis (NASH). However, LB remains a vastly controversial and debated subject. Histologic lesions of NASH are unevenly distributed throughout the liver parenchyma. Therefore, sampling error in liver biopsy can result in substantial misdiagnosis and staging inaccuracies. Additionally, though previous data suggested substantial or moderate concordance for some key histological NASH features (e.g fibrosis, ballooning degeneration), poor concordance in these components were reported in a recent trial.

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