NCT03259581已完成1 期
Safety of Transarterial Chemoembolization in Patients With Elevated Bilirubin
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Procedure related adverse events
研究概览
简要总结
The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hepatocellular carcinoma (HCC)
- •Direct or conjugated bilirubin < 3 mg/dl
- •Total bilirubin > 3 mg/dl
- •Willing and able to provide informed consent
- •>18 years of age
排除标准
- •Currently pregnant
- •Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference.
- •Arterial anatomy which would preclude selective transarterial chemoembolization
- •Patients who have a INR or platelet count which are not correctable to <1.8 and >35,000 respectively
- •Patients with extrahepatic metastases
- •Patients with portal vein invasion
结局指标
主要结局
Procedure related adverse events
时间窗: 1 month
Percentage of adverse events following TACE
次要结局
- Overall survival(24 months)
- Radiologic Response(1 month)
- Change in Child Pugh score(7 and 30 days)
- Change in Model for end stage liver disease (MELD)(7 and 30 days)
- Progression free survival(1, 3, 6, 12, 18, and 24 months)
研究者
研究点 (2)
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