跳至主要内容
临床试验/NCT02817685
NCT02817685Unknown不适用

Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 7,660 人开始时间: 2016年5月最近更新:
适应症

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

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

发起方
Third Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rongqin Zheng

Professor

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

Loading locations...

相似试验