Introducing HCC Surveillance in the Central Denmark Region
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 617
- 试验地点
- 6
- 主要终点
- HCC-related mortality
研究概览
简要总结
This study aims to investigate whether repeated 6-monthly screening for hepatocellular carcinoma (HCC) - called "HCC surveillance" - offered to selected patients with chronic liver disease can reduce HCC-related mortality by facilitating earlier detection of HCC. The screening procedure consists of two tests: an ultrasound examination of the liver and a blood sample to measure alpha-fetoprotein. Patients who screen positive on either examination will be offered standard work-up for HCC, typically beginning with a CT-scan.
In the study HCC surveillance will be offered to all patients with compensated non-viral cirrhosis residing in the Central Denmark Region, one of five administrative regions of Denmark. The study aims to determine the efficacy of HCC surveillance in reducing HCC-related mortality by comparing HCC-related mortality between the Central Denmark Region and the other four Danish regions, where HCC surveillance is not offered.
详细描述
Primary liver cancer is the sixth most common cancer and the third leading cause of cancer-related death. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and often develops in patients with chronic liver disease (cirrhosis), who have a substantially increased risk of HCC.
Because of this high risk, repeated screening for HCC, commonly referred to as HCC surveillance, is recommended by all major international liver societies. The hope is to identify HCC while curative treatment is still possible. In Denmark, HCC surveillance is only recommended for patients with cirrhosis caused by chronic viral hepatitis. Currently, it is not recommended to other patients with cirrhosis due to these patients' low risk of HCC and the lack of randomized studies to determine the efficacy of HCC surveillance as a means to reduce HCC-related or all-cause mortality.
On the study HCC surveillance is introduced for patients with compensated non-viral cirrhosis in the Central Denmark Region, one of Denmark's five administrative regions. Screening will consist of biannual abdominal ultrasound combined with alpha-fetoprotein (AFP) testing. Patients who screen positive will be offered standard work-up for HCC. 600 patients are expected to be enrolled and they will be offered three rounds of screening at 0, 6 months, and 12 months, i.e., there is no individual-level randomization in this study. Instead, national registry data will be used to compare HCC-related mortality (the primary outcome) and HCC incidence and other secondary outcomes between the Central Denmark Region and the other four Danish regions where HCC surveillance is not offered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis
- •No history of chronic hepatitis B or C
- •Compensated cirrhosis defined as:
- •No recent variceal bleeding, no uncontrolled ascites, no clinically apparent hepatic encephalopathy, and Child-Pugh score ≤ 8
- •Age 40-79 years
- •Expected remaining life expectancy ≥ 1 year
- •Not already in follow-up after treatment for HCC
- •No clinical suspicion of HCC
排除标准
- 未提供
研究组 & 干预措施
Assigned to HCC surveillance using 6-monthly abdominal ultrasound and alpha-fetoprotein
干预措施: Ultrasound of the liver and blood sample for alpha-fetoprotein (Diagnostic Test)
Assigned to standard of care
These patients are not followed within the study. Instead, patients in the target population from other regions in Denmark-who are comparable to those receiving the intervention-will serve as the comparison group.
结局指标
主要结局
HCC-related mortality
时间窗: From date of inclusion until death due to hepatocellular carcinoma or end of follow-up, assessed up to 30 months
HCC recorded as the underlying cause of death in the Danish Cause of Death Registry.
次要结局
- HCC incidence(From date of inclusion until diagnosis of hepatocellular carcinoma or end of follow-up, assessed up to 30 months.)
- All-cause mortality(From date of first screening to first occurrence of death from any cause assessed up to 30 months.)
- Use of diagnostic tests(From date of inclusion to first occurrence of death from any cause or diagnosis of hepatocellular carcinoma, assessed up to 30 months.)
- HCC-related mortality (sensitivity analysis)(From date of first screening to first occurrence of death from hepatocellular carcinoma, assessed up to 30 months.)
研究者
Peter Jepsen
Consultant Hepatologist, Professor, MD
University of Aarhus