Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

Renal Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00922948
• Other study ID #: IIS-001-09
• Status: Withdrawn
• Phase: Phase 2
• First received: June 16, 2009
• Last updated: July 26, 2016
• Start date: March 2010
• Est. completion date: March 2015

Study information

• Verified date: July 2016
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancers

Intervention

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

Locations

Country	Name	City	State
Canada	McMaster Institute of Urology - St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure rate.		Baseline, Weeks 6, 12, 24, 36, 48	No
Secondary	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	Yes
Secondary	Average percentage decrease in tumor size.		Baseline, Weeks 6, 12, 24, 36 and 48	Yes
Secondary	Intra and post-operative complications rates.		Weeks 6, 12, 24, 36 and 48	Yes
Secondary	Quality of life data.		Baseline, Weeks 6, 12, 24, 36 and 48	Yes