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Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03395379
Enrollment
90
Registered
2018-01-10
Start date
2012-01-11
Completion date
2016-05-15
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unrecognized Condition

Keywords

Radiofrequency, Thermal Protection, Percutaneous thermal ablation, Kidney neoplasms

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.

Interventions

PROCEDURERFA

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.

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Failure rate of the air dissection procedure6 weeks post-operativeThe 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

MeasureTime frameDescription
Post-operative complications6 weeks post-operativeMinor and major complications are recorded, corresponding to Clavien Dindo classification

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026