Initial Assessment of the Efficacy of Irreversible Electroporation in the Focal Treatment of Localized Renal Cell Carcinoma With Delayed-interval Kidney Tumor Resection (Irreversible Electroporation of Kidney Tumors Before Partial Nephrectomy [IRENE] Trial—An Ablate-and-Resect Pilot Study) - 11/04/18

Doi : 10.1016/j.urology.2017.12.016

Johann J. Wendler ^a,^*, ^{^{2
Study group IRENE trial featured by AKFM-DGU, Germany.},}^{^{3
Study group IRENE trial featured by DAfMT, Germany.}} , Maciej Pech ^b,^{^{3
Study group IRENE trial featured by DAfMT, Germany.}}, Frank Fischbach ^b,^{^{3
Study group IRENE trial featured by DAfMT, Germany.}}, Julian Jürgens ^b,^{^{3
Study group IRENE trial featured by DAfMT, Germany.}}, Björn Friebe ^b,^{^{3
Study group IRENE trial featured by DAfMT, Germany.}}, Daniel Baumunk ^f,^{^{2
Study group IRENE trial featured by AKFM-DGU, Germany.}}, Markus Porsch ^e, Simon Blaschke ^a, Daniel Schindele ^a, Sandra Siedentopf ^c, Jens Ricke ^g,^{^{3
Study group IRENE trial featured by DAfMT, Germany.}}, Martin Schostak ^a,^{^{2
Study group IRENE trial featured by AKFM-DGU, Germany.}}, Jens Köllermann ^d,^{^{1
These authors contributed equally to this work.},}^{^{2
Study group IRENE trial featured by AKFM-DGU, Germany.}}, Uwe B. Liehr ^a,^{^{1
These authors contributed equally to this work.},}^{^{2
Study group IRENE trial featured by AKFM-DGU, Germany.},}^{^{3
Study group IRENE trial featured by DAfMT, Germany.}}
^a Department of Urology, Otto von Guericke University of Magdeburg, Germany
^b Department of Radiology, Otto von Guericke University of Magdeburg, Germany
^c Department of Pathology, Otto von Guericke University of Magdeburg, Germany
^d Department of Pathology, Sana Medical Center Offenbach, Germany
^e Urological practice, Magdeburg, Germany
^f Urological practice, Stuttgart, Germany
^g Department of Radiology, Ludwig Maximilians University of Munich, Germany

^*Address correspondence to: Johann J. Wendler, M.D., Department of Urology, University of Magdeburg, Leipziger Str. 44, Magdeburg 39120, Germany.Department of UrologyUniversity of MagdeburgLeipziger Str. 44Magdeburg39120Germany

Abstract

Objective

To assess the efficacy of irreversible electroporation (IRE) ablation of pT1a renal cell carcinoma (RCC) in the first prospective, monocentric phase 2a pilot ablate-and-resect study (Irreversible Electroporation of Kidney Tumors Before Partial Nephrectomy [IRENE] trial). It has been postulated that focal IRE can bring about complete ablation of soft-tissue tumors with protection of healthy peritumoral tissue and anatomic structures.

Patients and Methods

The first 7 study patients with biopsy-proven pT1a RCC (15-39 mm) underwent IRE. Percutaneous computed tomography-guided IRE was performed with electrocardiographic triggering under general anesthesia and deep muscle paralysis with 3-6 monopolar electrodes positioned within the renal tumor. Twenty-eight days later, the tumor region was completely resected to confirm tumor destruction pathologically. Individual results for these patients are displayed, described, and discussed.

Results

Technical feasibility was attained in all patients, but electrode placement and ablation were complex, with a mean overall procedure time of 129 minutes. There were no major complications. Partial kidney resection was performed in 5 patients, and radical nephrectomy was performed in 2 patients because of central tumor location and ablation areas. Resections revealed by tumor, node, and metastasis classification of the International Union for Cancer Control 2017 no residual tumor as complete ablation in 4 cases (ypT0V0N0Pn0R0) and microscopic residual tumor cells as incomplete ablation in the other 3 cases (ypT1aV0N0Pn0R1).

Conclusion

Renal percutaneous IRE appears to be a safe treatment for pT1a RCC but requires substantial procedural effort. Resection specimens of the ablation zone revealed a high rate of microscopic incomplete ablation 4 weeks after IRE. According to these initial study results, curative, kidney-sparing ablation of T1a RCC appears possible but needs technical improvement to ensure complete ablation.

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Plan

Patients and Methods

Study Design and Approval

Procedures

Imaging

Histopathologic Analysis

Results

IRE Treatment

Magnetic Resonance Imaging

Side Effects

Resection and Histologic Analysis

Discussion

Limitations

Conclusion

	Financial Disclosure: The authors declare that they have no relevant financial interests.
	Compliance with Ethical Standards: All procedures performed and the conduct of the study as a whole were in accordance with the 1964 Helsinki Declaration and its later amendments and comparable ethical standards.