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临床试验/NCT03395379
NCT03395379已完成不适用

Air Dissection in Percutaneous Radiofrequency Ablation of T1a Renal Cell Carcinoma

Centre Hospitalier Universitaire de Nice0 个研究点目标入组 90 人开始时间: 2012年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
Failure rate of the air dissection procedure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who have already received a RFA treatment for an other tissu or tumor
  • Patients who have a bleeding tumor or prior local treatment

结局指标

主要结局

Failure rate of the air dissection procedure

时间窗: 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.

次要结局

  • Post-operative complications(6 weeks post-operative)

研究者

申办方类型
Other
责任方
Sponsor

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