Zero-ischemia Robot-assisted Partial Nephrectomy Using Near-infrared Fluorescence: A Prospective, Monocentric, Randomized, Comparative and Open-label Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Benefit on postoperative renal function of fluorescence-enhanced super-selective clamping during robot assisted partial nephrectomy compared with robot-assisted partial nephrectomy with renal artery clamping
研究概览
简要总结
Patients with renal cancer are commonly treated by robot-assisted partial nephrectomy. Renal artery clamping is commonly required inducing kidney ischemia during surgery. It impacts parenchymal and renal function. This study aims to compare a new surgical procedure in order to reduce ischemia effect and preserve renal function after partial nephrectomy for renal tumour.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •candidate for a robot-assisted partial nephrectomy for renal tumour
- •patient affiliated to social security
- •signature of the informed consent
排除标准
- •proven or suspected allergy to the indocyanine green
- •coagulation disorder contraindicating robot assistance in the partial nephrectomy
- •medical pathology contraindicating pneumo-peritoneum
- •multiple tumors
- •horseshoe kidney
- •exclusion period of another interventionnal study
- •protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
结局指标
主要结局
Benefit on postoperative renal function of fluorescence-enhanced super-selective clamping during robot assisted partial nephrectomy compared with robot-assisted partial nephrectomy with renal artery clamping
时间窗: 6 months
The glomerular filtration rate (GFR) of the kidney operated is assessed at 6 months after surgery. This value is compared to that assessed before the surgery to see the variation. This variation is compare between the two groups.
次要结局
- Number of group conversion in the zero ischemia method.(6 months)
- Surgical duration in the two groups(6 months)
- Complications(1 month)
- Per-surgery blood loss(1 month)
- Hemoglobine rate variation(1 month)
- Positive surgical margins(1 month)
- Variation between global GFR in the two groups(6 months)
- Renal parenchyma preserved(6 months)