Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

St. Joseph's Healthcare Hamilton

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Renal Cancers

Interventions

CryoablationPROCEDURE

Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.

Radiofrequency ablationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Treatment failure rate.

Time frame: Baseline, Weeks 6, 12, 24, 36, 48

Secondary Outcomes

Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance.

Time frame: Baseline, Weeks 6, 12, 24, 36 and 48

Average percentage decrease in tumor size.

Time frame: Baseline, Weeks 6, 12, 24, 36 and 48

Intra and post-operative complications rates.

Time frame: Weeks 6, 12, 24, 36 and 48

Quality of life data.

Time frame: Baseline, Weeks 6, 12, 24, 36 and 48

Data from ClinicalTrials.gov

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