Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

Study Overview
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Brief Summary
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The purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.

Detailed Description
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By enrolling all patients treated with CA or RFA, this study will document for the first time the safety and the short and long term efficacy of CA compared to RFA as well as provide urologists and decision makers currently unavailable information on CA in Canada.

Official Title
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A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses

Conditions
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Renal Cancers

Intervention / Treatment
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* Procedure: Cryoablation
* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with tumors that progress in size while on a watchful waiting protocol; Patients with multiple tumors; Patients with a tumor in a solitary kidney; Patients with poor renal function and a renal tumor; Patients with significant co-morbidities that may benefit from a less invasive approach. Exclusion Criteria: Large tumors > 4.0cm; Unable to have a general anesthetic; Unable to comply with follow-up protocol (i.e., routine CT or MRI and a follow-up biopsy); Uncorrectable bleeding diathesis; Evidence of metastatic disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoablation<br> | Procedure: Cryoablation<br>* Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.<br>|
| Active Comparator: Radiofrequency ablation<br>Radiofrequency ablation | Procedure: Radiofrequency ablation<br>* Thermal injury is the predominant mechanism of action of RFA. A high-frequency alternating current emitted from the exposed noninsulated portion of the electrode generates frictional heat, agitating ions in the tissue surrounding the tip of the needle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure rate. |  | Baseline, Weeks 6, 12, 24, 36, 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance. |  | Baseline, Weeks 6, 12, 24, 36 and 48 | 
| Average percentage decrease in tumor size. |  | Baseline, Weeks 6, 12, 24, 36 and 48 | 
| Intra and post-operative complications rates. |  | Weeks 6, 12, 24, 36 and 48 | 
| Quality of life data. |  | Baseline, Weeks 6, 12, 24, 36 and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency ablation, Cryosurgery, Renal cancers