Robot-Assisted Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage : Clinical Outcomes of a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The changes of estimated GFR (eGFR)
研究概览
简要总结
To evaluate the feasibility and efficiency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 T1a 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' 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 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
研究组 & 干预措施
Robot-assisted laparoscopic RFA assisted TE
RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping.
干预措施: zero ischemia robot-assisted laparoscopic RFA assisted TE (Procedure)
Robot-Assisted laparoscopic partial nephrectomy
The tumor then will be laparoscopic enucleation without hilar clamping.
干预措施: zero ischemia robot-assisted laparoscopic partial nephrectomy (Procedure)
结局指标
主要结局
The changes of estimated GFR (eGFR)
时间窗: baseline and 12 months
12 months minus baseline
The absolute change in glomerular filtration rate (GFR) of the affected kidney
时间窗: baseline and 12 months
12 months minus baseline
次要结局
- estimated blood loss(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(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)
- changes in GFR of total kidneys by renal scintigraphyby of 6 month(baseline and 6 months)