Single-center Randomized Trial for Comparison of Performance Between Domestic and Imported Chemoport
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- function of chemoport
研究概览
简要总结
To compare the performance of domestic chemoport and imported chemoport
详细描述
chemoport implantation was done by two investigator Chemoport type was randomly rendered. Domestic chemoport(Human port) and imported chemoport (Celsite) were used. chemoport function will be followed up.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who will receive chemotherapy via implantable port
- •age >20 years
- •expected life time > 6 months
- •lab test (platelet>50K, PT INR <2.0)
排除标准
- •performance status >2
- •brain metastasis
- •expected life time less than 6 months
- •age less than 20 years
- •active infection
- •severe heart dysfunction
- •recent myocardial infarct
研究组 & 干预措施
Celsite
patients received celsite chemoport implantation under local anesthesia
干预措施: Celsite chemoport implantation (Device)
Celsite
patients received celsite chemoport implantation under local anesthesia
干预措施: local anesthesia (Procedure)
Humanport
patients received Humanport chemoport implantation under local anesthesia
干预措施: local anesthesia (Procedure)
Humanport
patients received Humanport chemoport implantation under local anesthesia
干预措施: Humanport chemoport implantation (Device)
结局指标
主要结局
function of chemoport
时间窗: 6 months
Whether or not chemoport function is intact will be assessed. Chemoport function will be rendered as intact when chemotherapeutic agent is well infused through the chemoport. Chemoport function will be rendered as not intact when chemotherapeutic agent could be infused through the chemoport.
次要结局
- infection(6 months)
- Skin dehiscence(6 months)
- deep vein thrombosis(6 months)
- Fibrin sheath(6 months)
研究者
Hyo-Cheol Kim
Clinical Assistant Professor
Seoul National University Hospital