ireversible electroporation of kidney tumors before partial nephrectomy.

Conditions: Kidney Tumor; Renal Cell Cancer

Summary: the aim of the study is the evaluation of the ablation efficiency of the percutaneous irreversible electroporation (ire) as primary ablation therapy of locally confined renal cell carcinoma (≤4cm, see inclusion and exclusion criteria). the ablation success will be proofed by magnet resonance imaging (mri) and histologically after partial kidney resection or nephrectomy 4 weeks after ire. hypotheses: kidney tumors ≤4cm can be ablated completely by percutaneous ire. surrounded structures and renal tissue can be preserved.

health condition or problem studied: 1. international statistical classification of diseases and related health problems, tenth revision (icd10): c64 - malignant neoplasm of kidney, except renal pelvis 2. icd10: d41.0 - neoplasm of uncertain or unknown behaviour: kidney interventions/observational groups arm 1: 1. initial diagnostical examination of the renal mass. 2. if any extended diagnostical examination for treatment planning. 3. day -29 to -1: recruitment. 4. day -1: mri of the kidney, karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment. 5. day 0: percutaneous diagnostical biopsy with histopathological investigation and therapeutically, ct- and/or ultrasound-guided, ecg-synchronized irreversible electroporation (ire) of the kidney tumor in endotracheal anaesthesia und muscle relaxation. use of 1-6 ire probes with 90-100 pulses of 1500-3000 volts und 20-50 amperes each. 6. day 1-7: postinterventional follow-up: mri of the kidneys, karnofsky, physical examination, blood chemistry, urosonography, life quality assessment. 7. day 27: postinterventional follow-up: mri of the kidneys, karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment. 8. day 28: open surgery partial kidney resection or tumor nephrectomy of the ire treated kidney resp. kidney tumor region with histopathological investigation. 9. day 29-37: postoperative follow-up: physical examination, blood chemistry, urosonography, life quality assessment. 10. day 112: study-follow-up: mri of the kidneys, karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment. termination of the study. 11. study closed, individual follow-up due to the european association of urology guideline. recruitment: * (anticipated or actual) date of first enrollment: 2013/10/14 * planned/actual: opened * target sample size: 20 * monocentric/multicentric trial: monocentric trial * national/international: national

Eligibility criteria:
inclusion criteria: * one or more localized, resectable kidney tumors (≤4 cm) suspicious of malignancy or histology -proven renal cell cancer (rcc) * patients desire for therapy and surgical therapy * karnofsky-index \>70% * age ≥ 18 years * life expectancy ≥ 12 month * compliance of the patient taking part in a study * informed consent exclusion criteria: * violation against one or more inclusion criteria * cardial pacemaker or other electrical implants * qt-interval \>550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ecg-synchronisation unfeasible * known cardial ejection fraction \< 30% or nyha iii or iii-iv * known epilepsy * second malignancy (except basal-cell carcinoma and cervical carcinoma in situ) * immunosuppression or hiv-positive patients * active infection or severe health interference, that make taking part in a study unfeasible * pregnancy, lactation period, no contraception * metastatic disease * palliative status * running or executed rcc therapy * taking part in another clinical study for rcc * inoperable * rejection of interventional or surgical therapy by the patient * circulatory instability * general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation * psychiatric disorders that make taking part in a study or giving informed consent unfeasible * haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia * thromboplastin time ≤50 %, thrombocytes ≤50 gpt/l; partial thromboplastin time \>50 * mri incompatibility * metal implants \<1 cm closed to the kidney / kidney tumor * contraindication for biopsy and punction of the renal tumor under ct-guidance * untreated urinary retention * renal pelvis tumor, suspected transitional cell cancer

Keywords: kidney tumor renal cell cancer rcc irreversible electroporation ire partial kidney resection percutaneous ablation irene