Liver biopsy and the ‘gold standard’ debate

The birth of Hepatology as a defined clinical discipline coincides with the introduction of Menghini's needle in the late 1950s.1 In those days, very little was known about the aetiology of liver disease and in the majority of patients diagnosis was mainly based on the morphological examination of liver specimens obtained with a biopsy. Features such as necrosis, inflammation and fibrosis were not precisely categorised, and the final label was merely descriptive—that is, chronic persistent, chronic active hepatitis and cirrhosis. In these terms, liver biopsy was the only available diagnostic means, and truly represented a gold standard. The introduction of the so-called ‘one second needle biopsy of the liver’ was characterised since the beginning by a significant cooperative effort between the clinician and the pathologist. Clinical hepatologists were trained in liver pathology and this led to the foundation of the main academic schools of Hepatology in Europe and the USA.

The introduction of scoring systems represented a step forward in the use of liver biopsy. This introduction implied the necessity for more precision in the evaluation of liver biopsy specimens that was beyond the description and, in many instances, the opinion of the pathologist. Overall, the introduction of scoring systems was supposed to facilitate the comparison between samples and the communication of the results according to a global agreement. However, this obvious advantage, once analysed by statistical studies, started to be criticised in term of reproducibility, intraobserver and interobserver agreement, etc. For these and other reasons (sampling error, lack of standards, etc.), the value of liver biopsy as gold standard started to become questionable for clinicians. These issues started to be quite evident when liver biopsy was used to assess the extent of disease progression in terms of fibrotic transformation of the liver tissue, and even more when the …