Irreversible Electroporation(IRE) For Unresectable Renal Tumors

Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.

By enrolling patients with renal tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for renal tumors .

Inclusion Criteria:

• unresectable kidney tumors
• patients refused surgical therapy
• Karnofsky-index >70%
• Age ≥ 18 and ≤ 80 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
• an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
• QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
• active infection or severe health interference, that make taking part in a study unfeasible
• pregnancy, lactation period
• 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
• untreated urinary retention
• severe hepatic dysfunction
• any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
• taking part in another clinical study for renal tumor.