Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Completed

• Conditions: Unrecognized Condition
• Interventions: Procedure: RFA

• Registration Number: NCT03395379
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

The investigators aimed to evaluate the feasibility and safety of using ambient air to protect against thermal injury during RadioFrequency Ablation (RFA) for Renal Cell Carcinoma (RCC) based on data from cases at their institute.

Detailed Description

The incidence of renal cell carcinoma (RCC) has been increasing, particularly among patients \>65 years of age. As older individuals are at higher risk for surgical complications, the use of radiofrequency ablation (RFA) for small renal masses (SRM) \<4 cm in size, which include T1a tumors,may be a compelling treatment option for elderly patients. However, RFA uses heat to destroy abnormal tissue, with the risk of thermal injury to tissues and organs, including gastric tissue and nerve roots, which are in proximity to the targeted treatment zone. The incidence rate of major complication with RFA, including thermal wounds, has been reported to vary between 3.2% and 5.2%. Different thermal protection methods have been developed to lower the risk of injury to adjacent tissues during ablation, such as air dissection using CO2 injection and hydrodissection using G5% for shielding. Although both of these options are effective, they are expensive. To lower the cost of thermal protection, the investigators have been using ambient air instead of CO2 for air dissection prior to RFA for SRM-RCCs.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-01-11
• Primary Completion: 2016-03-15
• Study Completion: 2016-05-15
• Status Verified: 2017-12
• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-09
• Last Update Submitted: 2018-01-09
• Study First Posted: 2018-01-10
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with Renal Cell Carcinoma (RCC)
• Patients with a single SRM of <4 cm, confirmed as RCC on biopsy
• RCC status : pT1a
• Eligible patients for an RadioFrequency Ablation (RFA) treatment

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Exclusion Criteria

• Patients who have already received a RFA treatment for an other tissu or tumor
• Patients who have a bleeding tumor or prior local treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	RFA	RFA with air dissection protection
Group 1	RFA	RFA without air dissection protection

Primary Outcome Measures

Name	Time	Method
Failure rate of the air dissection procedure	6 weeks post-operative	The failure rate of the air dissection procedure is defined as the need for another dissection method, the inability to create sufficient space for successful dissection and/or damage to surrounding vital tissues.

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	6 weeks post-operative	Minor and major complications are recorded, corresponding to Clavien Dindo classification