Chronic Hepatitis B Clinical Trial
Official title:
Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial
This study is a randomized control prospective study. The aim of this study is to establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC.
Surveillance of chronic hepatitis B and cirrhotic patients had been demonstrated to increase
chances of curative treatment for hepatocellular carcinoma. However, the optimal
surveillance interval for different risk patients is still controversial. The AASLD and
EASL-EORTC guidelines recommend chronic hepatitis B patients undergoing ultrasound
surveillance at a time interval of 6 months, but the Japanese HCC guideline recommend the
very-high risk patients undergoing ultrasound surveillance at a time interval of 3 or 4
months.
The incidence of HCC is 0.3%-0.8% in the chronic hepatitis B patients and 2%-8% in cirrhotic
patients, thus recalling a different follow-up strategy for different stage of chronic
hepatitis B patients. Besides, ultrasound is the admitted surveillance tool for HCC for its
convenience and cost-effectiveness. However, the sensitivity of ultrasound detecting HCC
will remarkably decrease because of the influence of ribs, pulmonary and gastrointestinal
gas, cirrhosis and fatty liver. So it is necessary to incorporate computed tomography (CT)
or magnetic resonance imaging (MRI) into the follow-up strategy of very high risk patient
such as patients with cirrhosis or history of HCC.
The aim of this study is to investigate whether different surveillance time intervals and
surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with
different risk of HCC, ultimately establish an all-round and convenient follow-up strategy
of Chronic Hepatitis B for early detection and diagnosis of HCC.
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Observational Model: Cohort, Time Perspective: Prospective
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