Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

July 26, 2016 updated by: Anil Kapoor, St. Joseph's Healthcare Hamilton

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • McMaster Institute of Urology - St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoablation
Procedure: Cryoablation
Cryoneedles and one temperature probe are inserted under endoscopic and sonographic guidance.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment failure rate.
Time Frame: Baseline, Weeks 6, 12, 24, 36, 48
Baseline, Weeks 6, 12, 24, 36, 48

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, Weeks 6, 12, 24, 36 and 48
Average percentage decrease in tumor size.
Time Frame: Baseline, Weeks 6, 12, 24, 36 and 48
Baseline, Weeks 6, 12, 24, 36 and 48
Intra and post-operative complications rates.
Time Frame: Weeks 6, 12, 24, 36 and 48
Weeks 6, 12, 24, 36 and 48
Quality of life data.
Time Frame: Baseline, Weeks 6, 12, 24, 36 and 48
Baseline, Weeks 6, 12, 24, 36 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIS-001-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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