NCT00922948撤回2 期
A Prospective Randomized Pilot Trial of Cryoablation (CA) Versus Radio Frequency Ablation (RFA) for the Management of Small Renal Masses
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Treatment failure rate.
研究概览
简要总结
The purpose of this study is to verify the oncological efficacy and safety of cryoablation and radiofrequency ablation for the treatment of small renal tumors.
详细描述
By enrolling all patients treated with CA or RFA, this study will document for the first time the safety and the short and long term efficacy of CA compared to RFA as well as provide urologists and decision makers currently unavailable information on CA in Canada.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tumors that progress in size while on a watchful waiting protocol;
- •Patients with multiple tumors;
- •Patients with a tumor in a solitary kidney;
- •Patients with poor renal function and a renal tumor;
- •Patients with significant co-morbidities that may benefit from a less invasive approach.
排除标准
- •Large tumors > 4.0cm;
- •Unable to have a general anesthetic;
- •Unable to comply with follow-up protocol (i.e., routine CT or MRI and a follow-up biopsy);
- •Uncorrectable bleeding diathesis;
- •Evidence of metastatic disease.
结局指标
主要结局
Treatment failure rate.
时间窗: Baseline, Weeks 6, 12, 24, 36, 48
次要结局
- Quality of life data.(Baseline, Weeks 6, 12, 24, 36 and 48)
- Renal function - GFR of less than 60 ml per min per 1.73 m2. Serum creatinine and creatinine clearance.(Baseline, Weeks 6, 12, 24, 36 and 48)
- Average percentage decrease in tumor size.(Baseline, Weeks 6, 12, 24, 36 and 48)
- Intra and post-operative complications rates.(Weeks 6, 12, 24, 36 and 48)
研究者
Anil Kapoor
MD, FRCSC
St. Joseph's Healthcare Hamilton
研究点 (2)
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