A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
18 Years
90 Years
Both
Renal Cancers
Trial Information
A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment failure rate.
Outcome Time Frame:
Baseline, Weeks 6, 12, 24, 36, 48
Safety Issue:
No
Principal Investigator
Anil Kapoor, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
McMaster Institute of Urology, McMaster University
Authority:
Canada: Ethics Review Committee
Study ID:
IIS-001-09
NCT ID:
NCT00922948
Start Date:
March 2010
Completion Date:
October 2014
Related Keywords:
- Renal Cancers
- Radiofrequency ablation
- Cryosurgery
- Renal cancers
- Carcinoma, Renal Cell
- Kidney Neoplasms
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