EsophageAl mulTisegmented Fully covERed Self-expandable Metal Stent for Malignant Strictures: a Safety and Feasibility Study (EATERS Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia.
Study design: Prospective observational nonrandomized clinical study.
Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study.
Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS.
Primary end points:
- Safety: complications and adverse events during follow-up with special attention to stent migration rates;
- Efficacy: technical success of stent placement.
Secondary end points:
- Recurrent dysphagia including its cause;
- Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up);
- Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up);
- Pain related to esophageal stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
- •Requiring treatment for dysphagia (Ogilvie score of 2-41);
- •Life expectancy of less than 12 months.
排除标准
- •Stenosis after laryngectomy;
- •Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
- •Esophageal fistula;
- •Tumor length of more than 14 cm;
- •Previous stent placement for the same condition;
- •Inappropriate cultural level and understanding of the study;
- •Coagulopathy;
- •Patients with eosinophilic esophagitis or an esophageal motility disorder;
- •Nickel titanium (Nitinol) allergy.
研究组 & 干预措施
FC-SEMS
Placement of multisegmented fully covered self-expandable metal stent
干预措施: Multisegmented fully covered self-expandable metal stent (Device)
结局指标
主要结局
Adverse events
时间窗: 6 months
Adverse events during follow-up
Technical success of stent placement
时间窗: 1 day
Technical success of stent placement
次要结局
- Recurrent dysphagia(6 months)
- Functional outcome(6 months)
- Tissue ingrowth or overgrowth(6 months)
- Pain related to esophageal stent(6 months)