Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Conditions
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Unrecognized Condition

Intervention / Treatment
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* Procedure: RFA


Participation Criteria
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Eligibility Criteria
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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 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>RFA without air dissection protection | Procedure: RFA<br>* Radiofrequency ablation (RFA) is a medical procedure in which part of the electrical conduction system of the tumor is ablated using the heat generated from medium frequency alternating current.<br>|
| Group 2<br>RFA with air dissection protection | Procedure: RFA<br>* Radiofrequency ablation (RFA) is a medical procedure in which part of the electrical conduction system of the tumor is ablated using the heat generated from medium frequency alternating current.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate of the air dissection procedure | 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. | 6 weeks post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | Minor and major complications are recorded, corresponding to Clavien Dindo classification | 6 weeks post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous thermal ablation, Radiofrequency, Thermal Protection, Kidney neoplasms