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Completed

NCT Number: NCT03395379

Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RFA

Procedure

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.

Primary outcomes

  1. Failure rate of the air dissection procedure

    Time frame: 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 outcomes

  1. Post-operative complications

    Time frame: 6 weeks post-operative

    Minor and major complications are recorded, corresponding to Clavien Dindo classification

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2018
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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