Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00922948

Enrollment

Registered

2009-06-17

Start date

2010-03-31

Completion date

2015-03-31

Last updated

2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cancers

Keywords

Radiofrequency ablation, Cryosurgery, Renal cancers

Brief summary

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

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.

Interventions

PROCEDURECryoablation

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

PROCEDURERadiofrequency ablation

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Treatment failure rate.	Baseline, Weeks 6, 12, 24, 36, 48

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026