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Upper-Urinary-Tract Effects After Irreversible Electroporation (IRE) of Human Localised Renal-Cell Carcinoma (RCC) in the IRENE Pilot Phase 2a Ablate-and-Resect Study

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Abstract

Purpose

Irreversible electroporation (IRE) is a new potential ablation modality for small renal masses. Animal experiments have shown preservation of the urine-collecting system (UCS). The purpose of this clinical study was to perform the first evaluation and comparison of IRE’s effects on the renal UCS by using urinary cytology, magnetic-resonance imaging, and resection histology in men after IRE of pT1a renal-cell carcinoma (RCC).

Methods

Seven patients with biopsy-proven RCC pT1a cN0cM0 underwent IRE in a phase 2a pilot ablate-and-resect study (IRENE trial). A contrast-enhanced, diffusion-weighted MRI and urinary cytology was performed 1 day before and 2, 7, and 27 days after IRE. Twenty-eight days after IRE the tumour region was completely resected surgically.

Results

Technical feasibility was demonstrated in all patients. In all cases, MRI revealed complete coverage of the tumour area by the ablation zone with degenerative change. The urographic late venous MRI phase (urogram scans) demonstrated normal morphological appearances. Urine cytology showed a temporary vacuolisation of the cyto- and caryoplasmas after IRE. Whereas the urothelium showed signs of regeneration 28 days after IRE-ablation, the tumour and parenchyma below it showed necrosis and permanent tissue destruction.

Conclusions

Renal percutaneous IRE appears to be a safe treatment for pT1a RCC. The preservation of the UCS with unaltered normal morphology as well as urothelial regeneration and a phenomenon (new in urinary cytology) of temporary degeneration with vacuolisation of detached transitional epithelium cells were demonstrated in this clinical pilot study.

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Author information

Author notes

  1. M. Böhm and U. B. Liehr have contributed equally to this work.

Authors and Affiliations

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

    J. J. Wendler, S. Blaschke, D. Schindele, M. Schostak & U. B. Liehr

  2. Department of Radiology, Otto von Guericke University of Magdeburg, Magdeburg, Germany

    M. Pech, B. Friebe, J. Jürgens & F. Fischbach

  3. Department of Pathology, Otto von Guericke University of Magdeburg, Magdeburg, Germany

    S. Siedentopf

  4. Department of Pathology, Sana Medical Center Offenbach, Offenbach, Germany

    J. Köllermann

  5. Urological Practice, Magdeburg, Germany

    M. Porsch

  6. Urological Practice, Stuttgart, Germany

    D. Baumunk

  7. Department of Radiology, Ludwig Maximilians University of Munich, Munich, Germany

    J. Ricke

  8. Urological Practice, Dill-Clinics, Dillenburg, Germany

    M. Böhm

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  1. J. J. Wendler
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Corresponding author

Correspondence to J. J. Wendler.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical Approval

All procedures performed and the conduct of the study as a whole was in accordance with the 1964 Helsinki declaration and its later amendments and comparable ethical standards. Approval was obtained for the study by the national research committee (BfArM) and the institutional ethics committee.

Informed Consent

Informed consent was obtained from all subjects in this study. Additional informed consent for identifying information was not required.

Additional information

M. Böhm: Working group urine cytology and urine-based markers of the German Society of Urology (DGU).

Study group IRENE trial featured by AKFM-DGU (J. J. Wendler, J. Köllermann, D. Schindele, D. Baumunk, M. Schostak, U. B. Liehr) and DAfMT (J. J. Wendler, M. Pech, B. Friebe, J. Jürgens, F. Fischbach, J. Ricke, U. B. Liehr), Germany.

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Wendler, J.J., Pech, M., Köllermann, J. et al. Upper-Urinary-Tract Effects After Irreversible Electroporation (IRE) of Human Localised Renal-Cell Carcinoma (RCC) in the IRENE Pilot Phase 2a Ablate-and-Resect Study. Cardiovasc Intervent Radiol 41, 466–476 (2018). https://doi.org/10.1007/s00270-017-1795-x

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