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不可逆电穿孔治疗肾细胞癌的初步人体临床试验研究。

Irreversible electroporation of renal cell carcinoma: a first-in-man phase I clinical study.

机构信息

Department of Radiology and Nuclear Medicine, University of Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany.

出版信息

Cardiovasc Intervent Radiol. 2011 Feb;34(1):132-8. doi: 10.1007/s00270-010-9964-1. Epub 2010 Aug 15.

DOI:10.1007/s00270-010-9964-1
PMID:20711837
Abstract

PURPOSE

Irreversible electroporation (IRE) is a newly developed nonthermal tissue-ablation technique in which high-voltage electrical pulses of microsecond duration are applied to induce irreversible permeabilisation of the cell membrane, presumably through nanoscale defects in the lipid bilayer, leading to apoptosis. The purpose of this study was to assess the feasibility and safety of ablating renal cell carcinoma (RCC) tissue by IRE.

METHODS

Six patients scheduled for curative resection of RCC were included. IRE was performed during anaesthesia immediately before the resection with electrographic synchronisation. Central haemodynamics were recorded before and 5 min after electroporation. Five-channel electrocardiography (ECG) was used for detailed analysis of ST waveforms. Blood sampling and 12-lead ECG were performed before, during, and at scheduled intervals after the intervention.

RESULTS

Analysis of ST waveforms and axis deviations showed no relevant changes during the entire study period. No changes in central haemodynamics were seen 5 min after IRE. Similarly, haematological, serum biochemical, and ECG variables showed no relevant differences during the investigation period. No changes in cardiac function after IRE therapy were found. One case of supraventricular extrasystole was encountered. Initial histopathologic examination showed no immediate adverse effects of IRE (observation of delayed effects will require a different study design).

CONCLUSION

IRE seems to offer a feasible and safe technique by which to treat patients with kidney tumours and could offer some potential advantages over current thermal ablative techniques.

摘要

目的

不可逆电穿孔(IRE)是一种新开发的非热组织消融技术,其中应用微秒持续时间的高电压电脉冲诱导细胞膜不可逆的通透性,可能是通过脂质双层中的纳米级缺陷,导致细胞凋亡。本研究的目的是评估通过 IRE 消融肾细胞癌(RCC)组织的可行性和安全性。

方法

纳入 6 名计划接受根治性肾切除术的 RCC 患者。IRE 在麻醉期间进行,与心电图同步。在电穿孔前后记录中心血液动力学。五导联心电图(ECG)用于 ST 波型的详细分析。在干预之前、期间和预定时间后进行血液采样和 12 导联心电图。

结果

ST 波型和轴偏差分析显示整个研究期间没有相关变化。IRE 后 5 分钟中心血液动力学没有变化。同样,血液学、血清生化和 ECG 变量在研究期间没有显示出相关差异。IRE 治疗后心脏功能没有变化。发现 1 例室上性早搏。初步组织病理学检查显示 IRE 无即刻不良反应(观察延迟效应需要不同的研究设计)。

结论

IRE 似乎为治疗肾脏肿瘤患者提供了一种可行且安全的技术,并可能比目前的热消融技术具有一些潜在优势。

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