Zero Ischemia 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
- 90
- 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
To evaluate the feasibility and efficiency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.
详细描述
Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 T1a presumed renal cell carcinoma
- •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
- •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 close to the calyces
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
次要结局
- estimated GFR (eGFR)(12 months)
- changes in GFR of total kidneys by renal scintigraphyby(baseline and 12 months)
- blood loss(during surgery)
- surgical margin(postoperative)
- postoperative complications(12 months)
- progression-free survival(12 months)
- local recurrence(12 months)
- the absolute change in glomerular filtration rate (GFR) of the affected kidney(baseline and 6 months)
- estimated GFR (eGFR) of 6 month(6 month)
- changes in GFR of total kidneys by renal scintigraphyby of 6 month(6 month)
研究者
Yiran Huang
Principal Investigator
RenJi Hospital