Spots Global Cancer Trial Database for IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.

Study Description

Brief 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.

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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