NL-OMON40496已完成4 期
Wallflex stent versus Egis stent for palliation of malignant dysphagia - WAVE-trial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 116 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
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
- •-Dysphagia due to an inoperable malignant obstruction of the esophagus or gastric cardia. Dysphagia is defined as: dysphagia score of 2-4, according to Ogilvie. Inoperable disease is defined as local tumor infiltration into surrounding organs, distant metastases or a poor general health due to serious concomitant disease
- •-Written informed consent
排除标准
- •-Evidence of tumor growth within 2 cm of the upper esophageal sphincter
- •-Tumor length > 12 cm
- •-Previous stent placement for the same condition
- •-Karnofsky performance scale of <40%
- •-Patients unfit to undergo conscious sedation
- •-Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study or unwilling to undergo follow-up assessments
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