Zero Ischemia Laparoscopic Radio Frequency/Microwave Ablation Assisted Enucleation of Renal Cell Carcinoma With T1 Stage
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- the change in glomerular filtration rate (GFR) of the affected kidney
研究概览
简要总结
Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
- •patients scheduled for laparoscopic nephron sparing surgery
- •patients agreeable to participate in this long-term follow-up study
排除标准
- •patients' aged >80 years
- •patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney
- •patients not able to tolerate the laparoscopic procedure
- •patients with previous renal surgery or history of any inflammatory conditions of the operative kidney
- •patients with the renal tumor involving urinary collecting system
研究组 & 干预措施
Zero Ischemia group
Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases.
干预措施: zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE) (Procedure)
Conventional group
Renal hilum will be accurately isolated and then the artery only will be clamped during surgery.
干预措施: conventional laparoscopic partial nephrectomy (Procedure)
结局指标
主要结局
the change in glomerular filtration rate (GFR) of the affected kidney
时间窗: Baseline and 30 months
changes of estimated GFR (eGFR)
时间窗: Baseline and 30 months
次要结局
- estimated blood loss(during surgery)
- postoperative complications(postoperative，up to 30 days)
- progression-free survival rate(through study completion, an average of 3 years)
- rates of positive surgical margin(postoperative，up to 2 weeks after surgery)
- operative time(During surgery)
- the rate of local recurrence(through study completion, an average of 3 years)
- Hospital stay time(The time from the surgery day to patient discharge, up to 2 weeks)
研究者
Yiran Huang
Director of Urology
RenJi Hospital