Zero Ischemia Robot-Assisted Microwave Ablation Assisted Suture-less Enucleation of Renal Cell Carcinoma With T1 Stage: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The absolute 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 robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.
详细描述
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 robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial. This project is based on the previous research and aims to develop an approach of the combination of intraoperative real time contrast-enhanced ultrasonography technology, sutureless technology and the zero ischemia robot-Assisted tumor enucleation of the kidney. By using the real time contrast-enhanced ultrasonography technology, the current shortcomings of the zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation were overcome. The degree of elimination was monitored during surgery to avoid excessive bleeding caused by insufficient ablation during the surgery. Beside, the difficulty of zero ischemia laparoscopic radio frequency ablation is reduced, and doctors can quickly grasp the learning curve of this technology.
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 robot-assisted laparoscopic nephron sparing surgery
- •patients with normal contralateral renal function (differential renal function of >40% as determined by radionuclide scintigraphy)
- •patients agreeable to participate in this long-term follow-up study
排除标准
- •patients' age >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 robot-assisted 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 or distance from the tumor edge to the collecting system ≤ 4 mm
结局指标
主要结局
The absolute change in glomerular filtration rate (GFR) of the affected kidney
时间窗: baseline and 12 months
12 months minus baseline
The changes of estimated GFR (eGFR)
时间窗: baseline and 12 months
12 months minus baseline
次要结局
- estimated blood loss(during surgery)
- changes in GFR of total kidneys by renal scintigraphyby(baseline and 12 months)
- surgical margin(postoperative up to 2 weeks after surgery)
- postoperative complications(postoperative up to 30 days)
- progression-free survival(12 months)
- local recurrence(12 months)
- operative time(During surgery)
- Hospital stay time(The time from the surgery day to patient discharge, up to 2 weeks)
- changes in GFR of total kidneys by renal scintigraphyby of 3 month(baseline and 3 months)