Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

This study is currently recruiting participants.

Verified December 2012 by St. Joseph's Healthcare Hamilton

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 16, 2009

Last Updated Date

December 11, 2012

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment failure rate. [ Time Frame: Baseline, Weeks 6, 12, 24, 36, 48 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00922948 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

Official Title ^ICMJE

A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Renal Cancers

Intervention ^ICMJE

Procedure: Cryoablation
Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.
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.

Study Arm (s)

Experimental: Cryoablation
Intervention: Procedure: Cryoablation
Active Comparator: Radiofrequency ablation
Radiofrequency ablation

Intervention: Procedure: Radiofrequency ablation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2014

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Anil Kapoor, MD	905.522.6536	kapoor4@mcmaster.ca
Contact: Camilla Tajzler, B.A, CCRA	905.522.1155 ext 35876	tajzlec@mcmaster.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00922948

Other Study ID Numbers ^ICMJE

IIS-001-09

Has Data Monitoring Committee

Responsible Party

Anil Kapoor, St. Joseph's Healthcare Hamilton

Study Sponsor ^ICMJE

St. Joseph's Healthcare Hamilton

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anil Kapoor, MD

McMaster Institute of Urology, McMaster University

Information Provided By

St. Joseph's Healthcare Hamilton

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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