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临床试验/NCT03169439
NCT03169439Unknown不适用

Irreversible Electroporation for Treatment of Solid Abdominal Tumors

Assiut University0 个研究点目标入组 25 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
主要终点
The ablation success

研究概览

简要总结

Irreversible electroporation (IRE) is a novel non-thermal ablation modality with promise for revolutionizing the treatment for local solid tumors.

With the growing demand for alternative and less invasive treatments for localized tumors, the investigators have seen the development and investigation of several tissue ablation modalities, including radiofrequency ablation (RFA), microwave ablation, and cryoablation. Although these modalities have been efficacious, they have some disadvantages owing to their reliance on thermal energy for creating cell death.

详细描述

Irreversible electroporation is novel in that it does not use thermal energy, but electrical energy to produce focused cell death while sparing the normal extracellular matrix, nearby vessels, and structures, while allowing for rapid normal tissue regrowth.

Unlike thermal ablation modalities, Irreversible electroporation does not require significant consideration for dissipation of thermal energy, or heat sink, and has less complications relating to damage of normal soft tissue, eliminating a major cause of treatment failure.

Irreversible electroporation is a novel minimally invasive tumor/tissue ablation technique that can be used under guidance of ultrasound (US) or computed tomography (CT), without inducing thermal damaging effects, and with preservation of the surrounding vital structures such as vessels, bile ducts, urethra, and nerves which remain intact to function normally, even in locally advanced tumors. The technique depends upon inducing apoptotic non-necrotic cell death in short procedure time.

It has the advantage of allowing quick tissue regeneration. Irreversible electroporation treatment time is significantly shorter than traditional thermal ablation modalities, usually in few minutes range, and allows for treating considerably larger lesions than thermal ablation modalities.

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

入选标准

  • Patients with unresectable solid abdominal tumors (hepatic, pancreatic, porta hepatis,...).
  • The mass measures less than 4 cm.
  • Associated with no or oligo metastatic lesions

排除标准

  • Patients with cardiac arrhythmia and pacemaker.
  • Patients unfit for general anesthesia.
  • The lesion size is larger than 4 cm.

结局指标

主要结局

The ablation success

时间窗: 3 months

the ability to deliver planned therapy and to have no residual

次要结局

  • Local recurrence(3,6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jolie Welson

principle investigator

Assiut University

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