Study Stopped
Cryoablation is no longer offered at our hospital, and likely won't be offered in the near future.
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJuly 27, 2016
July 1, 2016
5 years
June 16, 2009
July 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment failure rate.
Baseline, Weeks 6, 12, 24, 36, 48
Secondary Outcomes (4)
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
Study Arms (2)
Cryoablation
EXPERIMENTALRadiofrequency ablation
ACTIVE COMPARATORRadiofrequency ablation
Interventions
Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anil Kapoor, MD
McMaster Institute of Urology, McMaster University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, FRCSC
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
March 1, 2010
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
July 27, 2016
Record last verified: 2016-07