NCT02822066Unknown1 期
Effectivity and Safety of Irreversible Electroporation for Refractory Neoplasms in Liver and Pancreas
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 60 patients of refractory neoplasms in liver and pancreas with irreversible electroporation-related effectivity as assessed by MRI
研究概览
简要总结
The pupose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for refractory neoplasms in liver and pancreas, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hepatic portal focal lesion adjacent to important structures like bile duct and portal blood vessels, or intolerant surgery.
- •Patients with pancreatic cancer adjacent to blood vessels, or intolerant surgery.
排除标准
- •Patients with:
- •Metal in the body
- •ChildPugh ≥ 3
- •Long-term use of anticoagulant drugs including warfarin, clopidogrel bisulfate
- •Poor cardiac or renal function with intolerant surgery or anesthesia.
结局指标
主要结局
60 patients of refractory neoplasms in liver and pancreas with irreversible electroporation-related effectivity as assessed by MRI
时间窗: up to 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
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