Ablation of Hepatocellular Carcinoma: a Nationwide Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- Recurrence after ablation
研究概览
简要总结
Background Hepatocellular carcinoma (HCC) is the most common primary malignancy in the liver. Chronic infection with hepatitis C virus (HCV) is a significant risk factor and may be associated with inferior outcome. According to the Danish national guidelines, ablation should be offered patients with early HCC (tumor < 3 cm) in a cirrhotic liver, who are not transplant candidates. However, the effect of size of the HCC tumor and Hepatitis C virus (HCV) as etiology are insufficiently investigated.
Purposes
- Investigate association between HCC tumor size and survival and recurrence after ablation.
- Investigate survival and recurrence after ablation in patients with HCV-related HCC compared with HCC due to other etiologies.
Methods This study is based on data from the Danish Liver and Bile Duct Cancer Database (DLGCD) and the Danish Database for Hepatitis B and C (DANHEP) and the laboratory database (DANVIR), which collectively include information on patient characteristics, tumor characteristic, laboratory results, and information regarding ablation, HCV status, and antiviral treatment, respectively.
Perspectives Ablation has been widely used for decades, but studies investigating the effect of ablation for HCC in patients with HCV and size of HCC are lacking. This study will contribute considerably to the level of evidence and may impact both Danish and international guidelines for HCC treatment.
详细描述
Background Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver and accounts for 85-90% of liver cancer. The most important risk factor for HCC is cirrhosis of any etiology. Among other major risk factors for HCC are chronic viral infections with hepatitis C virus (HCV) and hepatitis B virus (HBV), chronic alcohol consumption and non-alcoholic steatohepatitis.
Three nationwide databases and medical records will be used to address these important knowledge gaps. First, the association between survival and recurrence after ablation and HCC tumor size will be investigated. Second, the survival and recurrence after ablation in patients with HCC related to HCV will be investigated. due to HCV is different from that in patients with HCC due to other reasons than HCV. The nationwide data in these databases will reflect general clinical practice in an unselected population and provide novel information.
Purpose
With data from the Danish Liver and Bile Duct Cancer Database (DLGCD), the Danish Database for Hepatitis B and C (DANHEP), the National hepatitis laboratory database (DANVIR), and medical records, prognostic factors for survival in a large cohort of patients with HCC treated with ablation therapy will be investigated with the following aims:
- Investigate association between HCC tumor size and survival and recurrence after ablation therapy.
- Investigate survival and recurrence after ablation therapy in patients with HCV-related HCC compared with HCC due to other etiologies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma
- •Age > 18 years
- •Ablation as the first surgical treatment for HCC
排除标准
- •Hepatic resection or transplantation prior to ablation
- •Ablation performed in conjunction with resection
- •Ablation for recurrence of HCC
结局指标
主要结局
Recurrence after ablation
时间窗: January 2013 through August 2022
Recurrence by Aalen-Johansen estimator and Fine-Gray proportional subhazards model, death and transplantation as competing risks
Overall survival related to tumor size
时间窗: January 2013 through August 2022
Overall survival will be estimated by Kaplan-Meier methods with log-rank tests, and Cox proportional hazards regression model
次要结局
- Overall survival related to HCV virus(January 2013 through August 2022)
研究者
Hans-Christian Pommergaard
Cand.med., ph.d., clinical associate professor
Rigshospitalet, Denmark