Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 7,660
- 试验地点
- 1
- 主要终点
- The incidence of Hepatocellular carcinoma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBV-Ag positive( >6 months)
- •age among 18 and 80 years
排除标准
- •patients with hepatocellular carcinoma
- •patients were diagnosis hepatocellular carcinoma within 3 months of inclusion;
- •patients with alcoholic hepatitis or autoimmune hepatitis
- •patients with severe uncontrolled disease resulting in estimated life expectance less than 1 year
- •coinfection with human immunodeficiency virus(HIV)
- •cannot undergo contrast-enhanced imaging
- •refuse attending the study
结局指标
主要结局
The incidence of Hepatocellular carcinoma
时间窗: 3 year
次要结局
未报告次要终点
研究者
Rongqin Zheng
Professor
Third Affiliated Hospital, Sun Yat-Sen University
