NCT02969096Unknown2 期
Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
Shanghai University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of complete tumor ablation
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.
详细描述
A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of liver cancer based on histology or the current accepted radiological measures.
- •Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
- •Life expectancy: Greater than 3 months.
- •Patients' liver function is Child-pugh A or B.
- •Ability to understand the study protocol and a willingness to sign a written informed consent document.
- •Unable to receive operative surgery.
排除标准
- •Patients with other primary tumor except liver cancer.
- •History of coagulation disorders or anemia.
结局指标
主要结局
Rate of complete tumor ablation
时间窗: Up to 4 weeks post surgery
次要结局
- Adverse Events(Up to 4 weeks post surgery)
研究者
研究点 (1)
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