NCT03105921已完成不适用
Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
The aim of the study is to evaluate the use of irreversible electroporation in the treatment of locally advanced cancers of the head of pancreas with vascular spread. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.
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
- •Patients with histologically proven adenocarcinoma of the head of the pancreas (fine needle aspiration or biopsy)
- •Pancreatic adenocarcinoma locally advanced on imaging at diagnosis
- •Tumor of less than 7 cm in largest diameter
- •No chemotherapy or abdominal radiotherapy within five years before the inclusion in the study
排除标准
- •Pancreatic adenocarcinoma of more than 7 cm of diameter or immediately operable on imaging data
- •Patient with contraindication of NanoKnife use
- •Patient with neurostimulator
- •Epileptic patient or with a myocardial infarction lasting less than 2 months
- •Presence of visceral or lymph node metastases or peritoneal carcinosis at the initial workup
- •Patient who cannot be treated with muscle blockers (curare)
- •Patient with a metallic stent or a medical device implanted near the area treated by electroporation
研究组 & 干预措施
Electrodes
Experimental
Electrodes
干预措施: NanoKnife (Device)
结局指标
主要结局
R0 resection rate
时间窗: 3 months
Assessment of the R0 resection (complete tumour removal with negative resection margins) rate of locally advanced pancreatic cancer treated by electroporation
次要结局
未报告次要终点
研究者
研究点 (1)
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