Commentary
The topic of liver biopsy in clinical studies, such as for treatments for NASH, is highly important. Despite limitations, liver biopsy remains the gold standard for the study of liver disease. It is important for the exclusion of alternative diseases and co-morbidities such as autoimmune hepatitis or primary biliary cholangitis and provides unprecedented insights into the pathogenesis of the disease. T. Longerich and P. Schirmacher (Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany) make suggestions in the realization of future clinical studies:
– The length and width of a biopsy sample are crucial quality criteria
– The accuracy of feature definition is key for the development of a reliable histopathological scoring system
– Histopathological scoring systems should report the grade of disease activity and the stage of fibrosis
– The four-eye principle to reach consensus for study inclusion is recommended for histopathological studies
– Quantitative measurements should be considered as an addendum during study design.
