NCT02166320已完成2 期
The Importance of Stent Design
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- SEMS dislocation in cm during first thirty days after stent insertion.
研究概览
简要总结
Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Verified Squamous Cell Carcinoma or Adenocarcinoma of esophagus or Gastro Esophageal Junction (GEJ)
- •Age above 18 years.
- •Dysphagia scoring grade two or worse
- •Not amenable for curative treatment
- •Informed consent to participate
排除标准
- •Concomitant cancer disease
- •Inability to comply with study protocol
- •Previous stent treatment
- •Proximal location of the tumour in the esophagus.
- •Need for more than one stent deployment.
结局指标
主要结局
SEMS dislocation in cm during first thirty days after stent insertion.
时间窗: Thirty days from stent deployment.
次要结局
- Grade of dysphagia within three months of SEMS.(Three months after insertion.)
- Health Related Quality of Life (HRQOL)(Within three months of SEMS deployment.)
- Need for reintervention(Within three months after SEMS)
研究者
Lars Lundell
Professor
Karolinska University Hospital
研究点 (2)
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