Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

Phase 2

Withdrawn

• Conditions: Renal Cancers
• Interventions: Procedure: Cryoablation; Procedure: Radiofrequency ablation

• Registration Number: NCT00922948
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Study Timeline

• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Study Start: 2010-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoablation	Cryoablation	-
Radiofrequency ablation	Radiofrequency ablation	Radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
Treatment failure rate.	Baseline, Weeks 6, 12, 24, 36, 48

Secondary Outcome Measures

Name	Time	Method
Quality of life data.	Baseline, Weeks 6, 12, 24, 36 and 48
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

Trial Locations

Locations (1)

McMaster Institute of Urology - St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada