Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- absolute change in glomerular filtration rate (GFR) of the affected kidney
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.
详细描述
Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with 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
- •exophytic cancer
- •distance from the hilar renal vessels and urinary collecting system >= 1cm
- •patients with normal contralateral renal function (differential renal function of >40% as determined by renal scintigraphy)
- •patients giving consent to the participation in the current clinical trial
排除标准
- •patients with a history of other renal diseases, such as urinary lithiasis
- •patients with a history of renal surgery
结局指标
主要结局
absolute change in glomerular filtration rate (GFR) of the affected kidney
时间窗: baseline, 3 months and 12 months
measured by renal scintigraphy
次要结局
- progression-free survival(12 months)
- blood loss(during surgery)
- surgical margin(1 month)
- local recurrence(12 months)
- absolute change in eGFR of the affected kidney(baseline, 3 months, 6 months and 12 months)
- absolute change in total GFR(baseline and 6 months)
- operation time(during surgery)
- postoperative complications(up to 6 months)