Minimally-Invasive Isolated Limb Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Conversion to open surgery
研究概览
简要总结
The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.
详细描述
Isolated limb perfusion (ILP) and isolated limb infusion (ILI) are treatment options for patients with in-transit metastases of melanoma and locally advanced extremity sarcomas. There are several advantages for each method, but if the well-established effects of ILP could be combined to the minimally invasive approach of ILI, the results could be maximized and adverse events, related to open approach, minimized.
A new method for vascular approach (MI-ILP) will be evaluated in a phase I feasibility study. Percutaneous vascular access of the ipsilateral side will be performed by ultrasound guided technique and connected to an extracorporeal oxygenation system. Perfusion will be conducted in the same way as for open ILP. Outcomes, technical details and complications will be recorded prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The patient scheduled for treatment with isolated hyperthermic perfusion
- •Age over 18 years.
- •Signed informed consent
排除标准
- •Re-perfusion
- •Lymph node metastases
- •Severe atherosclerosis
结局指标
主要结局
Conversion to open surgery
时间窗: 1 day
Number of minimal-invasive procedure that will be converted to open surgery (per cent)
次要结局
- Response(3 months)
- Complications(30 days)
研究者
Roger Olofsson Bagge
Associate professor
Sahlgrenska University Hospital