Irreversible Electroporation(IRE) For Unresectable Renal Tumors

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

Detailed Description
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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 .

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

Conditions
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Renal Tumor

Intervention / Treatment
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* Procedure: irreversible electroporation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>irreversible electroporation with voltage in level A for renal tumors | Procedure: irreversible electroporation<br>* Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors<br>|
| Experimental: Group B<br>irreversible electroporation with voltage in level B for renal tumors | Procedure: irreversible electroporation<br>* Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors<br>|
| Experimental: Group C<br>irreversible electroporation with voltage in level C for renal tumors | Procedure: irreversible electroporation<br>* Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects | adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al. | 1 month | 
| Quality of Life (QoL) | Quality of Life assessed as WHOQOL-BREF. | 2 months | 
| procedural compliance | compliance will be analyzed by 3 months of follow-up post procedure. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | efficacy assessment by percentage of lesions that show no sign of recurrence 12 months after the initial IRE procedure) of IRE for renal tumor via cross-sectional imaging and pathological examination. | 12 months | 
| Voltage (A minimum and maximum range of voltage for safe and effective IRE) | A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irreversible electroporation, renal tumor