Treatment of Renal Tumors With Radiofrequency: Efficacy Evaluation in Comparison With Conservative Surgery (Multicentric Randomized Trial)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Carcinologic efficacy at the site of treatment,
研究概览
简要总结
Surgical treatment of multiple or recurrent renal tumors may be complicated by renal function impairment. Mini-invasive thermotherapy as radiofrequency (RF), induces necrosis of tumoral tissue while sparing normal renal parenchyma. The purpose of the study is to compare, in patients at risk of renal insufficiency, a strategy based on surgical approach and a strategy based on RF approach. 180 patients from 9 centers will be randomized in two groups (surgical vs. RF, delivered either percutaneously or under laparoscopy). The proportion of patients with a local carcinologic efficacy at 5 years and the general and renal tolerance will be analysed and compared between both strategies.
详细描述
Background. Surgical treatment of multiple or recurrent renal tumors may be complicated by renal function impairment. Mini-invasive thermotherapy as radiofrequency (RF), induces necrosis of tumoral tissue while sparing normal renal parenchyma.
Objectives. The main objective is to assess the 5-year local carcinologic efficacy (no residual tumor tissue and no recurrence at the site of treatment) of the radiofrequency treatment. Secondary objectives are to assess 5-year overall carcinologic efficacy, predictive factors of technical success of RF procedures, and the general and renal tolerance 5 years after treatment.
Study design. Open label, randomized, parallel-group, multicentric clinical trial (9 centers).
Eligibility criteria. Patients with renal tumor in whom a surgical treatment may result in renal function impairment.
Intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Solid kidney tumor: diameter <= 40mm, maximum volume 32cc
- •Intra-parenchymatous localization
- •At least one of the following criteria:
- •Patient of more than 70 years old
- •Hereditary kidney cancer (von Hippel-Lindau Disease disease, hereditary tubulopapillary carcinoma...)
- •Single kidney, with tumor difficult to reach to a conservative surgery (central-hilar or intra-parenchymatous tumour...)
- •Context of local recurrence after partial kidney surgery
- •Patient with impaired renal function (renal clearance < 30 ml/min)
- •Written informed consent
排除标准
- •Conservative surgery feasible in good technical and carcinological conditions
- •Contra-indication to either treatment
- •Kidney cancer metastases
结局指标
主要结局
Carcinologic efficacy at the site of treatment,
时间窗: at 5 years
次要结局
- Overall carcinologic efficacy(at 5 years)
- Carcinologic efficacy and lack of adverse consequences on renal function(at 5 years)
- Local technical success