Irreversible Electroporation for Treatment of Solid Abdominal Tumors
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with unresectable solid abdominal tumors (hepatic, pancreatic, porta hepatis,…).
- The mass measures less than 4 cm.
- Associated with no or oligo metastatic lesions
Exclusion Criteria:
- Patients with cardiac arrhythmia and pacemaker.
- Patients unfit for general anesthesia.
- The lesion size is larger than 4 cm.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：hepatic focal lesions and pancreatic masses
|
minimal invasive ablative technique for tumors
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The ablation success
大体时间：3 months
|
the ability to deliver planned therapy and to have no residual
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Local recurrence
大体时间：3,6 and 12 months
|
defined as re appearance of viable tumor after period during which no tumor could be detected
|
3,6 and 12 months
|
合作者和调查者
出版物和有用的链接
一般刊物
- Davalos RV, Mir IL, Rubinsky B. Tissue ablation with irreversible electroporation. Ann Biomed Eng. 2005 Feb;33(2):223-31. doi: 10.1007/s10439-005-8981-8.
- Edd JF, Horowitz L, Davalos RV, Mir LM, Rubinsky B. In vivo results of a new focal tissue ablation technique: irreversible electroporation. IEEE Trans Biomed Eng. 2006 Jul;53(7):1409-15. doi: 10.1109/TBME.2006.873745.
- Lee EW, Chen C, Prieto VE, Dry SM, Loh CT, Kee ST. Advanced hepatic ablation technique for creating complete cell death: irreversible electroporation. Radiology. 2010 May;255(2):426-33. doi: 10.1148/radiol.10090337.
- Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. doi: 10.1177/153303460700600401.
- Kasivisvanathan V, Thapar A, Oskrochi Y, Picard J, Leen EL. Irreversible electroporation for focal ablation at the porta hepatis. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1531-4. doi: 10.1007/s00270-012-0363-7. Epub 2012 Feb 25.
- Usman M, Moore W, Talati R, Watkins K, Bilfinger TV. Irreversible electroporation of lung neoplasm: a case series. Med Sci Monit. 2012 Jun;18(6):CS43-7. doi: 10.12659/msm.882888.
- Esser AT, Smith KC, Gowrishankar TR, Weaver JC. Towards solid tumor treatment by nanosecond pulsed electric fields. Technol Cancer Res Treat. 2009 Aug;8(4):289-306. doi: 10.1177/153303460900800406.
- Silk MT, Wimmer T, Lee KS, Srimathveeravalli G, Brown KT, Kingham PT, Fong Y, Durack JC, Sofocleous CT, Solomon SB. Percutaneous ablation of peribiliary tumors with irreversible electroporation. J Vasc Interv Radiol. 2014 Jan;25(1):112-8. doi: 10.1016/j.jvir.2013.10.012. Epub 2013 Nov 18.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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