Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

Sponsor

St. Joseph's Healthcare Hamilton (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00922948

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Mar 1, 2010

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Treatment failure rate. [Baseline, Weeks 6, 12, 24, 36, 48]

Secondary Outcome Measures

Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance. [Baseline, Weeks 6, 12, 24, 36 and 48]
Average percentage decrease in tumor size. [Baseline, Weeks 6, 12, 24, 36 and 48]
Intra and post-operative complications rates. [Weeks 6, 12, 24, 36 and 48]
Quality of life data. [Baseline, Weeks 6, 12, 24, 36 and 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster Institute of Urology - St. Joseph's Healthcare Hamilton	Hamilton	Ontario	Canada	L8N 4A6

Sponsors and Collaborators

St. Joseph's Healthcare Hamilton

Investigators

Principal Investigator: Anil Kapoor, MD, McMaster Institute of Urology, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton

ClinicalTrials.gov Identifier:

NCT00922948

Other Study ID Numbers:

IIS-001-09

First Posted:

Jun 17, 2009

Last Update Posted:

Jul 27, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton

Radiofrequency ablation

Cryosurgery

Renal cancers

Additional relevant MeSH terms:

Kidney Neoplasms

Carcinoma, Renal Cell

Study Results

No Results Posted as of Jul 27, 2016