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临床试验/NCT02495051
NCT02495051已完成不适用

Prevalence of Barrett's Esophagus in Adolescents and Young Adults With Esophageal Atresia

University Hospital, Lille20 个研究点 分布在 4 个国家目标入组 120 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
20
主要终点
presence of gastric and / or intestinal metaplasia diagnosed at histology

研究概览

简要总结

The frequency of Barrett's esophagus (BE) has increased in adults in the last decades, but BE is rare in children. Esophageal atresia (EA), the most common congenital anomaly affecting the esophagus, predisposes the patient to severe and prolonged gastroesophageal reflux disease. Because gastroesophageal reflux disease plays a major role in the development of BE by causing repeated mucosal damage, development of BE is a concern even in children and young adults in this specific population. The aim of this study is to assess the prevalence of BE (gastric and/or intestinal metaplasia) in a population of adolescents/young adults who had been treated for EA in early infancy. All eligible patients received upper gastrointestinal endoscopy under general anesthesia with standardized esophageal staged biopsies. Histological suspicion of metaplasia was confirmed centrally.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Medical history of esophageal atresia (all types, Ladd's classification)

排除标准

  • No medical history of esophageal atresia
  • Non acceptance to participate from the patient and/or his parents
  • esophageal atresia treated with esophageal replacement (e.g., coloplasty, gastric transposition)

结局指标

主要结局

presence of gastric and / or intestinal metaplasia diagnosed at histology

时间窗: during 2 hours of the endoscopy exam

Prevalence of Barrett's esophagus (gastric and/or intestinal metaplasia) in adolescents treated for esophageal atresia

次要结局

  • evaluation of the nutritional status(during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day))
  • presence of esophagitis or anomalies at the anastomotic stage diagnosed at histology(during 2 hours of the endoscopy exam)
  • evaluation of actual symptoms and treatment of gastroesophageal reflux disease(during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day))
  • evaluation of actual other symptoms (respiratory, dysphagia)(during the single visit scheduled, the day of endoscopy. This periode is corresponding at a day hospitalization (less than 12 hours in the day))

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (20)

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