renal cancer renal cell carcinoma
Conditions
Interventions
Patients will undergo IRE ablation of a renal tumour. The IRE procedure will
take place at the Intervention Radiology room at the OR complex under general
anesthesia with aditional muscle relaxation
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age * 18 years - Solid, enhancing mass on cross sectional imaging - Scheduled for a radical nephrectomy (open or laparoscopic)
Exclusion criteria
Exclusion criteria: - Irreversible bleeding disorders - Inability/unwillingness to interrupt anticoagulation therapy - Previous cryoablation, RFA or partial nephrectomy in affected kidney - Anasthesia Surgical Assignment (ASA), category * IV - ICD / pacemaker - Severe cardiovascular disease in medical history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The efficacy of IRE ablation of renal masses, measured by histopathologic examination of the target tumour by an experienced genitourinary pathologist. Using immunehistochemical staining to evaluate cell viability. 2. The safety of IRE ablation of renal masses, by evaluating device and procedural adverse events using CTCAE v4.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and three weeks post IRE ablation. By comparing MRI imaging to the histopathological examination results of the resected material. - The efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and three weeks post IRE ablation. By comparing CEUS imaging to the histopathological examination results of the resected material. | — |
Countries
Netherlands
Outcome results
None listed