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First Delayed Resection Findings After Irreversible Electroporation (IRE) of Human Localised Renal Cell Carcinoma (RCC) in the IRENE Pilot Phase 2a Trial

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Abstract

Introduction

It is postulated that focal IRE affords complete ablation of soft-tissue tumours while protecting the healthy peritumoral tissue. Therefore, IRE may be an interesting option for minimally invasive, kidney-tissue-sparing, non-thermal ablation of renal tumours.

Aim

With this current pilot study (“IRENE trial”), we present the first detailed histopathological data of IRE of human RCC followed by delayed tumour resection. The aim of this interim analysis of the first three patients was to investigate the ablation efficiency of percutaneous image-guided focal IRE in RCC, to assess whether a complete ablation of T1a RCC and tissue preservation with the NanoKnife system is possible and to decide whether the ablation parameters need to be altered.

Methods

Following resection 4 weeks after percutaneous IRE, the success of ablation and detailed histopathological description were used to check the ablation parameters.

Results

The IRE led to a high degree of damage to the renal tumours (1 central, 2 peripheral; size range 15–17 mm). The postulated homogeneous, isomorphic damage was only partly confirmed. We found a zonal structuring of the ablation zone, negative margins and, enclosed within the ablation zone, very small tumour residues of unclear malignancy.

Conclusion

According to these initial, preliminary study results of the first three renal cases, a new zonal distribution of IRE damage was described and the curative intended, renal saving focal ablation of localised RCC below <3 cm by percutaneous IRE by the NanoKnife system appears to be possible, but needs further, systematic evaluation for this treatment method and treatment protocol.

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    Authors and Affiliations

    1. Department of Urology, University Hospital, Otto von Guericke University of Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany

      Johann Jakob Wendler, Markus Porsch, Daniel Baumunk, Martin Schostak & Uwe-Bernd Liehr

    2. Institute of Pathology, Sana Klinikum Offenbach Am Main, Offenbach Am Main, Germany

      Jens Köllermann

    3. Department of Radiology, University of Magdeburg, Magdeburg, Germany

      Jens Ricke, Maciej Pech, Frank Fischbach & Julian Jürgens

    4. Institute of Pathology, University of Magdeburg, Magdeburg, Germany

      Sandra Siedentopf & Albert Roessner

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    1. Johann Jakob Wendler
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    Correspondence to Johann Jakob Wendler.

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    Conflict of Interest

    Author 10 (Martin Schostak) has received funding for conference attendance from AngioDynamics Inc. (New York, USA). Neither of these sources provided any input whatsoever into this article or this study. The other authors declare that they have no conflict of interest.

    Ethical Approval

    All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

    Informed Consent

    Informed consent was obtained from all individual participants included in this study. Additional informed consent for identifying information does not apply.

    Additional information

    Jens Köllermann and Uwe-Bernd Liehr have contributed equally.

    Johann Jakob Wendler, Jens Ricke, Maciej Pech, Frank Fischbach and Uwe-Bernd Liehr are with the German Academy for Microtherapy (DAfMT).

    Daniel Baumunk, Martin Schostak, Jens Köllermann and Uwe-Bernd Liehr are with the Working Group for Focal and Microtherapy of the Academy for German Urologists.

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    Wendler, J.J., Ricke, J., Pech, M. et al. First Delayed Resection Findings After Irreversible Electroporation (IRE) of Human Localised Renal Cell Carcinoma (RCC) in the IRENE Pilot Phase 2a Trial. Cardiovasc Intervent Radiol 39, 239–250 (2016). https://doi.org/10.1007/s00270-015-1200-6

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