Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00922948
Recruitment Status : Withdrawn (Cryoablation is no longer offered at our hospital, and likely won't be offered in the near future.)
First Posted : June 17, 2009
Last Update Posted : July 27, 2016
Information provided by (Responsible Party):
Anil Kapoor, 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.

Condition or disease Intervention/treatment Phase
Renal Cancers Procedure: Cryoablation Procedure: Radiofrequency ablation Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
Study Start Date : March 2010
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cryoablation Procedure: Cryoablation
Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.
Active Comparator: Radiofrequency ablation
Radiofrequency ablation
Procedure: Radiofrequency 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.

Primary Outcome Measures :
  1. Treatment failure rate. [ Time Frame: Baseline, Weeks 6, 12, 24, 36, 48 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Average percentage decrease in tumor size. [ Time Frame: Baseline, Weeks 6, 12, 24, 36 and 48 ]
  3. Intra and post-operative complications rates. [ Time Frame: Weeks 6, 12, 24, 36 and 48 ]
  4. Quality of life data. [ Time Frame: Baseline, Weeks 6, 12, 24, 36 and 48 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00922948

Canada, Ontario
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Principal Investigator: Anil Kapoor, MD McMaster Institute of Urology, McMaster University

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton Identifier: NCT00922948     History of Changes
Other Study ID Numbers: IIS-001-09
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016

Keywords provided by Anil Kapoor, St. Joseph's Healthcare Hamilton:
Radiofrequency ablation
Renal cancers

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type