Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors：The Safety and Efficacy Assessment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- effective rate of IRE ablation
研究概览
简要总结
Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that uses a series of short but intense electric pulses delivered by NanoKnife generator through paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis through irreversibly disrupting cellular membrane integrity. This study aimed to investigate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE） in the treatment of patients with locally advanced tumors in different anatomical position.
详细描述
This study is a multicenter, open-label trial that aimed to evaluate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE）in the treatment of patients with locally advanced tumors. Investigators will screen eligible patients and examine them by imaging tests as well as serological examination before and after the IRE procedures to assess the result with the size，blood supply，metabolism of tumors，the change of blood test and treatment-related complications. Big bore multislice spiral CT with thickness 5 cm, 120kilovolt，and 250milliampere，ECG-gated device and anesthesia monitoring equipment were selected during these procedures. Imaging (performed by contrast enhanced CT scan) and serological follow-up was at postoperative day 3 and 1，3，6，12months. The primary endpoint is the effective rate of IRE，and the secondary endpoint is 1-year survival rate and the frequency of adverse events. The response of irreversible electroporation ablation will be assessed according to the different evaluation criterions based on Response Evaluation Criteria in Solid Tumors.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced solid tumor.
- •Unresectable tumors or the patient refused surgical therapy.
- •Patients in good health conditions can receive general anesthesia.
- •Patients with good compliance can cooperate with doctors for related tests and the regular follow-up.
排除标准
- •Targeted tissues that metallic wallstents or metallics were implanted.
- •With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations.
- •With bleeding and psychiatric disorders.
- •Severe arrhythmia.
结局指标
主要结局
effective rate of IRE ablation
时间窗: up to 12 months after the procedures
The procedure-related result will be assess by the size，blood supply，metabolism of the tumors. The changes of blood test are also considerable.
次要结局
- 1-year survival rates(up to 12 months after the procedures)
- complication rate(During the procedure or up to 12 months after the ablation procedure)
研究者
Yueyong Xiao
Director of the Department
Chinese PLA General Hospital