Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.
Nephron sparring surgery has emerged as the procedure of choice for most patients with renal tumors that are \>2 cm and harbor a greater than 50% exophitic component. In order to decrease blood loss surgeons may: 1- interrupt blood flow to the kidney, completely or selectively; 2-Use diuretics such as mannitol to dehydrate the kidney; 3-Ice externally the kidney - in open procedures - to decrease metabolism during ischemia. The emergence of robotic surgery triggered a shift in the the surgical approach to partial nephrectomy and is commonly employed. A fundamental drawback of this technique is represented on the lack of cold ischemia. However, warm ischemia is commonly employed and requires dissection of the renal pedicle, which by itself puts the kidney at risk of loss.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Cryoablation Assisted Partial Nephrectomy is monitored under Ultrasound guidance, A Cryoablation machine (FDA Approved Device) along with its Cryoprobes are used in the study The Cryoprobes are placed in close to the endophytic tumor margins. The tumor boundary area will undergo one freezing cycles. Tumor is excised after 5 minutes of freezing cycle. Thawing process is passive, renal defect repair is conducted during thawing process.
Urological Research Network
Miami Lakes, Florida, United States
RECRUITINGRecurrence - Oncological Control
Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis
Time frame: 10 Years
Local Re-Intervention
Either subsequent ablation or surgical exploration or surgical kidney removal
Time frame: 10 Years
Development or Progression of Chronic Kidney Disease (CKD)
De-Novo emergence of CDK or changes in CKD overtime based on variation from baseline. The international classification for CKD defined by serum estimated Glomerular Filtration Rates (GFR) will be used as measurement instrument using the following definitions: GFR categories in CKD G1 ≥90 Normal or high G2 60-89 Mildly decreased\* G3a 45-59 Mildly to moderately decreased G3b 30-44 Moderately to severely decreased
Time frame: 10 Years
Incidence of Metastatic disease
patients will be evaluated using imaging studies at fixed intervals as follows: at 6 months Renal Ultrasound at 1 year CT Urogram at 18 Months, 24 months and yearly thereafter with Renal Ultrasound CT Urograms will be performed as needed for cause
Time frame: 10 Years
Survival
If a patient expiries during the study interval we would procure the death certificate and do our best to determine cause of death
Time frame: 10 years
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