Cryotherapy and Robotic Assisted Non Ischemic Nephron Sparring Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Recurrence - Oncological Control
研究概览
简要总结
Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.
详细描述
Nephron sparring surgery has emerged as the procedure of choice for most patients with renal tumors that are >2 cm and harbor a greater than 50% exophitic component. In order to decrease blood loss surgeons may: 1- interrupt blood flow to the kidney, completely or selectively; 2-Use diuretics such as mannitol to dehydrate the kidney; 3-Ice externally the kidney - in open procedures - to decrease metabolism during ischemia.
The emergence of robotic surgery triggered a shift in the the surgical approach to partial nephrectomy and is commonly employed. A fundamental drawback of this technique is represented on the lack of cold ischemia. However, warm ischemia is commonly employed and requires dissection of the renal pedicle, which by itself puts the kidney at risk of loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ages between 45-90-year-old.
- •Renal tumor ≤ 7 cm in the greatest extension, >50% exophitic.
排除标准
- •Prior renal surgery
- •M1 Disease
结局指标
主要结局
Recurrence - Oncological Control
时间窗: 10 Years
Recurrence at Site of Excision or within 1 cm of margin or Development of Metastasis
次要结局
- Survival(10 years)
- Local Re-Intervention(10 Years)
- Incidence of Metastatic disease(10 Years)
- Development or Progression of Chronic Kidney Disease (CKD)(10 Years)