Liver stiffness, noninvasively measured by transient elastography, correlates well with liver fibrosis stage. The aim of this prospective study was to evaluate the liver stiffness measurement (LSM) as a predictor of hepatocellular carcinoma (HCC) development among patients with chronic hepatitis C. Between December 2004 and June 2005, a total of 984 HCV-RNA positive patients, without HCC or a past history of it, visited the University of Tokyo Hospital. LSM was performed successfully in 866 patients, who gave informed consent. During the follow-up period (mean, 3.0 years), HCC developed in 77 patients (2.9% per 1 person-year). The cumulative incidence rates of HCC at 1, 2, and 3 years were 2.4%, 6.0%, and 8.9%, respectively. Adjusting for other significant factors for HCC development, patients with higher LSM were revealed to be at a significantly higher risk, with a hazard ratio, as compared to LSM <10 kPa, of 16.7 (95% confidence interval [CI], 3.71-75.2; P < 0.001) when LSM 10.1-15 kPa, 20.9 (95% CI, 4.43-98.8; P < 0.001) when LSM 15.1-20 kPa, 25.6 (95%CI, 5.21-126.1; P < 0.001) when LSM 20.1-25 kPa, and 45.5 (95% CI, 9.75-212.3; P < 0.001) when LSM >25 kPa. Conclusions: This prospective study has shown the association between LSM and the risk of HCC development in patients with hepatitis C. The utility of LSM is not limited to a surrogate for liver biopsy but can be applied as an indicator of the wide range of the risk of HCC development. (HEPATOLOGY 2009;49:1954-1961.) See Editorial on Page 1793
H epatocellular carcinoma (HCC) is a common malignancy worldwide, 1 currently showing an increasing incidence in the United States and elsewhere. 2-4 HCC usually develops in liver already suffering from chronic liver diseases. In particular, hepatitis C virus (HCV)-related cirrhosis is associated with an extremely high risk of HCC development, with a reported annual incidence ranging between 3% and 8%. The prognosis of HCC is deemed poor unless the cancer is detected and treated at an early stage. 8-10 Thus, the assessment of risk for HCC development is essential in the management of patients with chronic liver diseases.
Chronic hepatitis C is an endemic disease affecting millions of individuals globally. 11-14 HCV infection is typically accompanied by no conspicuous symptoms and may result in cirrhosis unnoticed over a couple of decades. The risk factors for hepatic carcinogenesis in patients with chronic hepatitis C have been vigorously studied, and the degree of liver fibrosis is known to be the strongest. Until recently, however, the degree of liver fibrosis could be reliably assessed only with liver biopsy, an invasive procedure with the possibility of life-threatening complications. Recently, liver stiffness measured noninvasively by transient elastography has been reported to be well correlated with histologically assessed liver fibrosis stage. Both routine and specific biomarkers, together with a combination thereof, have been proposed as noninvasive indicators of the degree of liver fibrosis. Among them, Fibrotest is accepted as a promising noninvasive marker to