NCT00600444已完成不适用
Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary success rate of the randomized intervention
研究概览
简要总结
The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal or greater than 18 years
- •Patients scheduled for primary elective implantation of TIAP
排除标准
- •Participation in another clinical trial which could interfere with the primary endpoint of this study
- •Lack of compliance
- •Impaired mental state or language problem
- •Patients with known allergy to contrast agent
研究组 & 干预措施
A
Active Comparator
Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
干预措施: Venae sectio (Procedure)
B
Experimental
Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.
干预措施: Punction of V. subclavia (Procedure)
结局指标
主要结局
Primary success rate of the randomized intervention
时间窗: Assessed on the day of surgery (day 0)
次要结局
- Peri-/postoperative complication rate for the randomized intervention(Assessed after 90 day post operation)
研究者
研究点 (1)
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