Zero Ischemia Laparoscopic Partial Nephrectomy in Combination With Superselective Renal Artery Embolization for Small Renal Masses: A Feasibility Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Warm ischemia time
研究概览
简要总结
Laparoscopic partial nephrectomy (LPN) is often reserved for patients with a small peripheral tumour, in the hands of an experienced surgeon since it demands a high degree of endoscopic skill. Renal vessel clamp for vascular control is a required step during standard LPN. However, this creates a time limiting step for the surgeon and induces renal injury via warm ischemia and reperfusion injury. This novel approach can substantially reduce renal injury during LPN via superselective embolization of level II renal arteries pre-operatively. This technique facilitates the performance of a clamp-less, zero-ischemia LPN, significantly simplifying the procedure by remove time thresholds within which to perform tumor excision. The preliminary results are promising; however, there is a need for further corroboration of their results, in addition to a randomized controlled trial comparing this modified, zero ischemia technique with standard LPN.
详细描述
The potential utility of a zero ischemia, laparoscopic, partial nephrectomy portends significant implications for both the surgeon and patient. Firstly, the technical difficulty of a partial nephrectomy will be reduced to a more achievable level owing mainly to the removal of a time limit on surgical resection. With the blood flow halted to downstream tissue containing the renal neoplasm from preoperative embolization, resection can be made to the tumor without clamping of the main renal arteries. This minimizes the ischemic time to non-neoplastic renal tissue, allowing for a renal protective effect. Without the need for clamping, the overall surgical operative time is drastically reduced. With excision made at the ischemic tissue, intra-operative bleeding and ease can be achieved. More surgeons can ultimately attempt at LPN by removing the single most limiting surgical factor, warm ischemic time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1a renal cell carcinomas diagnosed by ultrasonography (US), computed tomography (CT) or fine needle aspiration
- •tumor size <4cm in diameter
- •predominant exophytic growth
- •intraparenchymal depth no greater than 1.5cm, with a minimum distance of 5mm from the urinary collecting system
排除标准
- •predominant endophytic nature (depth </= 1.5 cm)
- •nearness (<0.5cm) of the tumor to the urinary collecting system
- •multiple ipsilateral lesions
- •pregnancy
- •allergy to intravenous contrast dye
- •absolute contraindications to surgical intervention
结局指标
主要结局
Warm ischemia time
时间窗: Duration of Surgical Procedure
From renal vessel clamping to unclamping during nephrectomy (only if clamping has occurred). Calculated in minutes.
Mean estimated blood loss (measured in ml)
时间窗: Duration of Surgical Procedure
From the start of procedure (Nephrectomy), until the end of the procedure.
Extirpative time
时间窗: Duration of Surgical Procedure
From initial renal tissue breach until completion of bolster placement. Calculated in minutes.
次要结局
- Blood transfusions(From date of pre-op up to 6 months post-op)
- Conversion to other type of surgery (i.e. Radical Nephrectomy)(Duration of Surgical Procedure)
- Mean hospital stay(2-10 Days)
- Overall survival rates(Up to 24 months post-operatively.)
- Pathological Results (% of negative margins and benign versus malignant tumours).(7 to 14 days post nephrectomy.)
- Identification of other complications (i.e. readmission, arteriovenous malformations)(Up to 24 months post-operatively.)
研究者
Anil Kapoor
MD, FRCSC
McMaster University