NL-OMON45573已完成4 期
Esophageal HILZO Covered self-expandable metal stent for palliation of malignant dysphagia: A Safety and Feasibility Study - HILZO-study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Non-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease.
- •Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer.
- •Requiring treatment for dysphagia (dysphagia score of 2-4, according to Ogilvie2)
- •Written informed consent
- •Age >= 18 years
排除标准
- •Inappropriate cultural level and understanding of the study.
- •Simultaneous participation in another clinical study
- •Life expectancy of less than 12 months
- •Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
- •Tumor length of more than 12cm
- •Coagulopathy
- •Previous stent placement for the same condition
研究者
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