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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
15
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Fuda Cancer Hospital
Guangzhou, Guangdong, China
adverse effects
adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.
Time frame: 1 month
Quality of Life (QoL)
Quality of Life assessed as WHOQOL-BREF.
Time frame: 2 months
procedural compliance
compliance will be analyzed by 3 months of follow-up post procedure.
Time frame: 3 months
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.
Time frame: 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.
Time frame: 3 months
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