Clinical Evaluation and Histological Analysis of Biopsies From the Upper Gastrointestinal Tract of Patients With and Without Symptoms of Reflux Disease (histoGERD Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
研究概览
简要总结
Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.
详细描述
Prospective multicenter study involving six clinical institutions (see collaborators) with recruitment of consecutive patients who undergo routine upper endoscopy for several (non-selected) reasons. The patients will have to fill out a questionnaire about their history of reflux symptoms, including questions regarding smoking and drinking habits. The treating physician will have to complete a clinical protocol which includes a questionnaire regarding the patient's drug history.
The endoscopic examination is done in a routine, yet standardized fashion. In particular, biopsy material will be taken from the stomach, the gastroesophageal junction and from the duodenum. The samples will be routinely sent to the participating institutes of pathology (see collaborators) and will be assessed by independent histopathologists with special expertise in gastrointestinal pathology.
Endoscopic findings are documented in a standardized clinical protocol. Likewise, the histopathological assessment of the samples is done following a standardized protocol following the WHO classification and the updated Sydney classification, as appropriate.
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
- 8 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)
研究者
Cord Langner, MD
MD, Senior Scientist
Medical University of Graz
