Irreversible Electroporation of Renal Cell Carcinoma: A First-in-Man Phase I Clinical Study
- 633 Downloads
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.
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.
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).
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.
KeywordsIrreversible electroporation Ablation Renal carcinoma Interventional radiology
Conflict of interest
The authors declare that they have no conflict of interest. This study was performed independently of the manufacturer of the devices used.
- 1.Bertacchini C, Margotti PM, Bergamini E, Lodi A, Ronchetti M, Cadossi R (2007) Design of an irreversible electroporation system for clinical use. Technol Cancer Res Treat 6(4):313–320Google Scholar
- 2.Rubinsky B, Onik G, Mikus P (2007) Irreversible electroporation: a new ablation modality—clinical implications. Technol Cancer Res Treat 6(1):37–48Google Scholar
- 3.Rubinsky B (2007) Irreversible electroporation in medicine. Technol Cancer Res Treat 6(4):255–260Google Scholar
- 4.Hines-Peralta A, Goldberg SN (2004) Review of radiofrequency ablation for renal cell carcinoma. Clin Cancer Res 10(18 Pt 2):6328S–6334SGoogle Scholar
- 5.Yoon SK, Choi JC, Cho JH, Oh JY, Nam KJ et al (2009) Radiofrequency ablation of renal VX2 tumors with and without renal artery occlusion in a rabbit model: feasibility, therapeutic efficacy, and safety. Cardiovasc Intervent Radiol 32(6):1241–1246Google Scholar
- 6.Ljungberg B, Hanbury DC, Kuczyk MA, Merseburger AS, Mulders PF, Patard JJ et al (2007) Renal cell carcinoma guideline. Eur Urol 51(6):1502–1510Google Scholar
- 7.Al Sakere B, André F, Bernat C, Connault E, Opolon P, Davalos RV, et al (2007) Tumor ablation with irreversible electroporation. PLoS One 2(11):e1135Google Scholar
- 8.Garcia PA, Rossmeisl JH, Robertson J, Ellis TL, Davalos RV (2009) Pilot study of irreversible electroporation for intracranial surgery. Conf Proc IEEE Eng Med Biol Soc 1:6513–6516Google Scholar
- 11.Frank I, Blute ML, Leibovich BC, Cheville JC, Lohse CM, Zincke H (2005) Independent validation of the 2002 American Joint Committee on cancer primary tumor classification for renal cell carcinoma using a large, single institution cohort. J Urol 173(6):1889–1892Google Scholar
- 13.Bell ET (1950) Renal diseases. Lippincott, Philadelphia, PA, pp 428–439Google Scholar
- 14.Peterson RO (1986) Urologic pathology. Lippincott, Philadelphia, PA, pp 85–110Google Scholar
- 16.Nissenkorn, Bernhelm J (1995) Multicentricity in renal cell carcinoma. J Urol 153(3 Pt 1):620–622Google Scholar
- 17.Chawla SN, Crispen PL, Hanlon AL, Greenberg RE, Chen DY, Uzzo RG (2006) The natural history of observed enhancing renal masses: meta-analysis and review of the world literature. J Urol 175(2):425–431Google Scholar
- 18.Mayo-Smith WW, Dupuy DE, Parikh PM, Pezzullo JA, Cronan JJ (2003) Imaging-guided percutaneous radiofrequency ablation of solid renal masses: techniques and outcomes of 38 treatment sessions in 32 consecutive patients. AJR Am J Roentgenol 180(6):1503–1508Google Scholar
- 19.Matlaga BR, Zagoria RJ, Woodruff RD, Torti FM, Hall MC (2002) Phase II trial of radio frequency ablation of renal cancer: evaluation of the kill zone. J Urol 168(6):2401–2405Google Scholar
- 21.Pavlovich C, Walther M, Choyke P, Pautler SE, Chang R, Linehan WM et al (2002) Percutaneous radiofrequency ablation of small renal tumors: initial results. J Urol 167(1):10–15Google Scholar
- 22.Tacke J, Mahnken A, Bucker A, Rohde D, Günther RW (2001) Nephron-sparing percutaneous ablation of a 5 cm renal cell carcinoma by superselective embolization and percutaneous RF-ablation. Rofo 173(11):980–983Google Scholar
- 23.Gebauer B, Werk M, Lopez-Hanninen E, Felix R, Althaus P (2007) Radiofrequency ablation in combination with embolization in metachronous recurrent renal cancer in solitary kidney after contralateral tumor nephrectomy. Cardiovasc Intervent Radiol 30(4):644–649Google Scholar
- 26.Maor E, Ivorra A, Leor J, Rubinsky B (2007) The effect of irreversible electroporation on blood vessels. Technol Cancer Res Treat 6(4):307–312Google Scholar