A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 10
- 主要终点
- Number of Participants With Recurrent Dysphagia.
研究概览
简要总结
The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-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
- 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
- •Malignant stricture of the esophagus or cardia
- •No curative treatment options available
- •Dysphagia grade of at least 2 (i.e. swallow semi-solid foods or less)
- •Informed consent
- •Age ≥ 18 years
排除标准
- •Previous treatment with self-expandable metal stent for same condition
- •Evidence of tumor within 2 cm of the upper esophageal sphincter.
- •Presence of an esophago-tracheal or -bronchial fistula or both.
- •Not able to undergo upper endoscopy
研究组 & 干预措施
Insertion of a Fully covered SEMS
干预措施: Fully covered SEMS (Device)
Insertion of a partially covered SEMS
干预措施: Partially covered SEMS (Device)
结局指标
主要结局
Number of Participants With Recurrent Dysphagia.
时间窗: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.
This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.
次要结局
- Number of Participants With Technical Success of SEMS Placement(At stent placement (t=0))
- Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score(From stent placement until death or placement of second stent, assessed up to 6 months.)
- Number of Participants in Whom a Major Complication Has Occured(From stent placement until death or placement of second stent, assessed up to 6 months)
- Median Survival After SEMS Placement(From stent placement until death or placement of second stent)
研究者
Manon Spaander
M.D., PhD
Foundation for Liver Research