Cryoablation Versus Radiofrequency Ablation for Small Renal Masses

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00922948
First received: June 16, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Renal Cancers
Procedure: Cryoablation
Procedure: Radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922948

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT00922948     History of Changes
Other Study ID Numbers: IIS-001-09
Study First Received: June 16, 2009
Last Updated: July 14, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Joseph's Healthcare Hamilton:
Radiofrequency ablation
Cryosurgery
Renal cancers

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 16, 2014