Renal Tumor
Conditions
Keywords
irreversible electroporation, renal tumor
Brief summary
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.
Detailed description
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 .
Interventions
PROCEDUREirreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Sponsors
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | 2 months | Quality of Life assessed as WHOQOL-BREF. |
| adverse effects | 1 month | adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al. |
| procedural compliance | 3 months | compliance will be analyzed by 3 months of follow-up post procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voltage (A minimum and maximum range of voltage for safe and effective IRE) | 3 months | A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice. |
| Recurrence rate | 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progress free disease (PFS) | 12 months | Patients will be followed for 12 months after IRE for PFS assessing. |
| Overall survival (OS) | 36 months | Patients will be followed for 36 months after IRE for OS analyzed. |
Countries
China
Outcome results
None listed