NCT02335827已完成不适用
Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial
Fuda Cancer Hospital, Guangzhou1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- adverse effects
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.
详细描述
By enrolling patients with renal tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for renal tumors .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •unresectable kidney tumors
- •patients refused surgical therapy
- •Karnofsky-index >70%
- •Age ≥ 18 and ≤ 80 years
- •life expectancy ≥ 12 month
- •compliance of the patient taking part in a study
- •informed consent
排除标准
- •violation against one or more inclusion criteria
- •an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
- •QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
- •active infection or severe health interference, that make taking part in a study unfeasible
- •pregnancy, lactation period
- •general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
- •psychiatric disorders that make taking part in a study or giving informed consent unfeasible
- •haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
- •thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time >50
- •untreated urinary retention
- •severe hepatic dysfunction
- •any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
- •taking part in another clinical study for renal tumor.
结局指标
主要结局
adverse effects
时间窗: 1 month
adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.
Quality of Life (QoL)
时间窗: 2 months
Quality of Life assessed as WHOQOL-BREF.
procedural compliance
时间窗: 3 months
compliance will be analyzed by 3 months of follow-up post procedure.
次要结局
- Recurrence rate(12 months)
- Voltage (A minimum and maximum range of voltage for safe and effective IRE)(3 months)
研究者
研究点 (1)
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