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临床试验/NCT02010983
NCT02010983已完成不适用

Screening for Dysplasia in Longstanding Idiopathic Achalasia: a Prospective Study

KU Leuven1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2013年10月1日最近更新:
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

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

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guy Boeckxstaens

Prof. Dr.

KU Leuven

研究点 (1)

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