Evaluation of the Efficacy of Radiofrequency Ablation in the Treatment of Renal Tumors: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 8
- 主要终点
- Rate of local efficacy of RFA treatment
研究概览
简要总结
Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and retrospectively in all centers to obtain the required number of patient followed during 5 years.
详细描述
Radiofrequency ablation (RFA) of renal cell carcinoma (RCC) is actually used in elderly patients with small renal tumors (diameter ≤ 4 cm) and presenting a high risk of surgery (due to co-morbidity) and/or reduced renal function. RFA is a minimally invasive technique, considered as an alternative to surgery to limit morbidity and to preserve kidney function. The technique is well known and has proven his efficacy for the treatment of small tumors.
An enlargement of the indications of RFA to patient without contra-indication to surgery will depend on the efficacy of the technique.
The main objective of the study is to evaluate the local efficacy of the ablation based on the technical success, and on the evaluation of local cancer recurrence over 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient treated with percutaneous RFA
- •Patient with diagnosis of renal masses with a maximum of 3 masses treated during the ablation
- •The diameter of the tumor must be ≤ 40 mm, characterized by CT-scan or MRI
- •The histology of the tumor must be biopsy-proven or the patient must have previous surgical ablation of renal tumor (ipsi or contralateral)
排除标准
- •Patient treated by surgery or laparoscopy
- •Benign tumors
- •No histological diagnosis (no biopsy or no previous treated renal carcinoma)
- •Patient having secondary malignant sites, ganglions or visceral metastatic cells or endo-venous extend at the time of RFA
- •Patient having a diagnosis of primary or secondary extra-renal tumor location and not into remission
- •Patients treated with antiangiogenic drugs during the 6 months prior RFA.
结局指标
主要结局
Rate of local efficacy of RFA treatment
时间窗: 60 months after the RFA treatment (D0)
次要结局
- Tolerance of the treatment(At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0))
- Overall success(At 60 months after the RFA treatment (D0))
- No recurrence of RCC(At 60 months after the RFA treatment (D0))