Clinical Trials Directory

Trials / Completed

CompletedNCT03395379

Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Status
Completed
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURERFARadiofrequency 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.

Timeline

Start date
2012-01-11
Primary completion
2016-03-15
Completion
2016-05-15
First posted
2018-01-10
Last updated
2018-01-10

Source: ClinicalTrials.gov record NCT03395379. Inclusion in this directory is not an endorsement.