Internal Jugular Vein Versus Axillary Vein With Single-incision for Implantable Ports: a Prospective and Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Early complications.
研究概览
简要总结
Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.
详细描述
Prospective and randomized trial comparing internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm in a single center study at AC Camargo Cancer Center. Every surgery is assisted by ultrasound and radioscopic and the catheter is districath®, 8.5 French. Clinical assessment will be at 10 days and every 3 months after surgery. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.
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
- •Catheter due to chemotherapy.
- •Cancer patients.
- •ECOG (performance status) from 0 to
- •Signed informed consent form.
排除标准
- •Non compliance.
- •Anticoagulant therapy.
- •Coagulopathy (platelet count below 50,000 and/or protrombin time above 18s).
- •Death within 30 days after the procedure.
- •Another catheter in superior vena cava.
- •Previous long term catheter in superior vena cava.
- •Obesity (IBM>40 Kg/m2).
结局指标
主要结局
Early complications.
时间窗: 30 days
Early complications within 30 days during clinical assessment. These outcomes are divided in intra-operative complications, such as pneumothorax, hemothorax, vascular injury, cardiac arrhythmia, hematoma; and post-operative until 30 days complications such as wound infections, catheter related bacteremia, catheter disfunction, catheter related deep venous thrombosis, reservoir extrusion and skin erosion.
次要结局
- Late complications(30 to 180 days)