Cryoablation Versus Radiofrequency Ablation for Small Renal Masses
This study is currently recruiting participants.
Verified December 2012 by St. Joseph's Healthcare Hamilton
Sponsor:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00922948
First received: June 16, 2009
Last updated: December 11, 2012
Last verified: December 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Renal Cancers |
Procedure: Cryoablation Procedure: Radiofrequency ablation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by St. Joseph's Healthcare Hamilton:
Primary Outcome Measures:
- Treatment failure rate. [ Time Frame: Baseline, Weeks 6, 12, 24, 36, 48 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Average percentage decrease in tumor size. [ Time Frame: Baseline, Weeks 6, 12, 24, 36 and 48 ] [ Designated as safety issue: Yes ]
- Intra and post-operative complications rates. [ Time Frame: Weeks 6, 12, 24, 36 and 48 ] [ Designated as safety issue: Yes ]
- Quality of life data. [ Time Frame: Baseline, Weeks 6, 12, 24, 36 and 48 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922948
Contacts
| Contact: Anil Kapoor, MD | 905.522.6536 | kapoor4@mcmaster.ca |
| Contact: Camilla Tajzler, B.A, CCRA | 905.522.1155 ext 35876 | tajzlec@mcmaster.ca |
Locations
| Canada, Ontario | |
| McMaster Institute of Urology - St. Joseph's Healthcare Hamilton | Recruiting |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Contact: Anil Kapoor, MD 905.5226536 kapoor4@mcmaster.ca | |
| Contact: Paul Whelan, MD 905.521.6014 whelanp@mcmaster.ca | |
| Principal Investigator: Anil Kapoor, MD | |
| Sub-Investigator: Paul Whelan, MD | |
| Sub-Investigator: Edward Matsumoto, MD | |
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
| Principal Investigator: | Anil Kapoor, MD | McMaster Institute of Urology, McMaster University |
More Information
No publications provided
| Responsible Party: | Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton |
| ClinicalTrials.gov Identifier: | NCT00922948 History of Changes |
| Other Study ID Numbers: | IIS-001-09 |
| Study First Received: | June 16, 2009 |
| Last Updated: | December 11, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by St. Joseph's Healthcare Hamilton:
|
Radiofrequency ablation Cryosurgery Renal cancers |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013