NCT02010983已完成不适用
Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- incidence of dysplasia in patients with longstanding achalasia
研究概览
简要总结
Patient with achalasia have a 10-50 fold increased risk to develop esophageal squamous cell carcinoma (ESCC). Early diagnosis of ESCC is essential, and detection of an earlier dysplastic stage is preferred. Endoscopic detection is however difficult and often delayed. Chromoendoscopy with Lugol dye increases detection rates dysplasia and ESCC to 91-100%. The aim of this study was therefore to evaluate a screening program using chromoendoscopy with Lugol to detect dysplasia in patients with idiopathic achalasia.
A second objective is to study the relationship between foodstasis and the development op dysplasia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •longstanding achalasia (> 15y)
- •> 18y old
- •informed consent
排除标准
- •allergy to iodine
- •esophageal carcinoma
结局指标
主要结局
incidence of dysplasia in patients with longstanding achalasia
时间窗: 1 year
次要结局
- additive value of chromoendoscopy in comparison with lugol stain(1 year)
- relationship between food stasis and dysplasia(1 year)
研究者
研究点 (1)
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