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Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

Primary Purpose

Renal Cancers

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Cryoablation
Radiofrequency ablation
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cancers focused on measuring Radiofrequency ablation, Cryosurgery, Renal cancers

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cryoablation

Radiofrequency ablation

Arm Description

Radiofrequency ablation

Outcomes

Primary Outcome Measures

Treatment failure rate.

Secondary Outcome Measures

Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance.
Average percentage decrease in tumor size.
Intra and post-operative complications rates.
Quality of life data.

Full Information

First Posted
June 16, 2009
Last Updated
July 26, 2016
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT00922948
Brief Title
Cryoablation Versus Radiofrequency Ablation for Small Renal Masses
Official Title
A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Cryoablation is no longer offered at our hospital, and likely won't be offered in the near future.
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancers
Keywords
Radiofrequency ablation, Cryosurgery, Renal cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryoablation
Arm Type
Experimental
Arm Title
Radiofrequency ablation
Arm Type
Active Comparator
Arm Description
Radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
Cryoablation
Intervention Description
Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
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 Measure Information:
Title
Treatment failure rate.
Time Frame
Baseline, Weeks 6, 12, 24, 36, 48
Secondary Outcome Measure Information:
Title
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
Title
Average percentage decrease in tumor size.
Time Frame
Baseline, Weeks 6, 12, 24, 36 and 48
Title
Intra and post-operative complications rates.
Time Frame
Weeks 6, 12, 24, 36 and 48
Title
Quality of life data.
Time Frame
Baseline, Weeks 6, 12, 24, 36 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Kapoor, MD
Organizational Affiliation
McMaster Institute of Urology, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

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Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

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