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Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Unrecognized Condition

Treatments

Procedure: RFA

Study type

Observational

Funder types

Other

Identifiers

NCT03395379
URO-BASE01

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

90 participants in 2 patient groups

Group 1
Description:
RFA without air dissection protection
Treatment:
Procedure: RFA
Group 2
Description:
RFA with air dissection protection
Treatment:
Procedure: RFA

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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