NCT01447667已完成不适用
Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of patients who experienced HCC recurrence after RFA
研究概览
简要总结
The purpose of this study is to determine:
- The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA treatment
- The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis
详细描述
To evaluate whether MRE score reflecting hepatic fibrosis can predict the recurrence of HCC within 2 years after RFA treatment
- Local recurrence/intrahepatic distant recurrence
- Multivariable analysis including several related factors to find whether MRE score is an independent predictor of HCC recurrence even after adjusting other factors (etiology of liver disease, size of HCC, vessel invasion, HBsAg titer, etc.)
To find the efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Diagnosed as single hypervascular hepatocellular carcinoma initially
- •AJCC stage I HCC
- •Child-Pugh class A
- •Planning radiofrequency ablation for HCC
- •Voluntary agreement for this study
排除标准
- •Decreased kidney function (GFR < 70 mL/min/kg)
- •Contraindication to MRI (pacemaker, defibrillator)
- •Contrast media hypersensitivity
- •Other primary malignancy
- •Acute viral hepatitis
- •Prior history of liver transplantation
- •Thrombosis in splenic vein or portal vein
- •Patients who were enrolled to other clinical trials within 4 weeks
- •Other severe chronic disease or psychiatric disease
- •Pregnant or milk-feeding women
- •Patients with coagulopathy, high risk of bleeding for the liver biopsy
- •Patients who disagree to participate in this study
结局指标
主要结局
Number of patients who experienced HCC recurrence after RFA
时间窗: within 2 years after RFA procedure
To see whether MRE score reflecting hepatic fibrosis predicts the recurrence of HCC within 2 years after RFA treatment
次要结局
- Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score(2 years after RFA)
研究者
Jung-Hwan Yoon
Clinical professor, M.D., Ph.D.
Seoul National University Hospital
研究点 (1)
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