Hepatocellular carcinoma surveillance is supported by a randomized clinical trial (RCT) in patients with chronic hepatitis B but only has level II evidence in patients with cirrhosis. Although several cohort studies suggest HCC surveillance is associated with increased early HCC detection and improved survival in patients with cirrhosis and HCC, these studies have notable limitations including lead time and length time biases. Further, the net benefit of HCC surveillance is determined by these potential benefits weighed against the risk of physical, psychological, and financial harms as well as the risk of overdiagnosis. Although screening-related harms are mild in most patients, there are some patients with indeterminate results who have higher cumulative harms given repeated diagnostic testing. Given uncertain benefits and risk of potential harms, there is sufficient equipoise to warrant a randomized clinical trial evaluating HCC surveillance in patients with cirrhosis. However, there are barriers to conducting such a trial including the required time scale to demonstrate a mortality benefit as well as concerns about acceptance by patients and providers.

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Should a Randomized Controlled Trial of Hepatocellular Carcinoma Surveillance in Patients with Cirrhosis Be Performed?

  • Ian A. Rowe

摘要

Hepatocellular carcinoma surveillance is supported by a randomized clinical trial (RCT) in patients with chronic hepatitis B but only has level II evidence in patients with cirrhosis. Although several cohort studies suggest HCC surveillance is associated with increased early HCC detection and improved survival in patients with cirrhosis and HCC, these studies have notable limitations including lead time and length time biases. Further, the net benefit of HCC surveillance is determined by these potential benefits weighed against the risk of physical, psychological, and financial harms as well as the risk of overdiagnosis. Although screening-related harms are mild in most patients, there are some patients with indeterminate results who have higher cumulative harms given repeated diagnostic testing. Given uncertain benefits and risk of potential harms, there is sufficient equipoise to warrant a randomized clinical trial evaluating HCC surveillance in patients with cirrhosis. However, there are barriers to conducting such a trial including the required time scale to demonstrate a mortality benefit as well as concerns about acceptance by patients and providers.