NCT01867931已完成不适用
Characterisation of Esophageal Epithelial Damage in Patients With Non-erosive Reflux Disease (NERD) and Erosive Esophagitis (EE): Role of Epithelial Permeability
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Epithelial integrity in tissue biopsies
研究概览
简要总结
The purpose of this study is to characterize and compare epithelial damage in patients with erosive esophagitis and non-erosive reflux disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Typical GERD-symptoms lasting for more than 6 months (recurrent episodes of heartburn or acid regurgitation)
- •abnormal pH-parameters (pathological acid exposure and/or symptom association)
排除标准
- •Age <18 years
- •Previous esophageal or gastric surgery
- •Severe esophageal motility disorder on manometry
- •Histological evidence of Barrett's mucosa
- •Severe co-morbidities (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorders and co-morbidity hindering a gastroscopic procedure)
- •Use of anticoagulant or immunosuppressive drugs
- •Inability to stop medication that can influence the test results, like PPI, for at least 10 days before tests
- •Excessive alcohol consumption (>20 units per week)
- •Patients unable to give informed consent.
结局指标
主要结局
Epithelial integrity in tissue biopsies
时间窗: 1 year
次要结局
- Immunohistochemical markers in tissue biopsies(1 year)
- Histological changes in tissue biopsies(1 year)
研究者
研究点 (1)
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