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临床试验/NCT01576289
NCT01576289已完成不适用

Clinical Evaluation and Histological Analysis of Biopsies From the Upper Gastrointestinal Tract of Patients With and Without Symptoms of Reflux Disease (histoGERD Trial)

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2011年11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
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

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

发起方
Medical University of Graz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cord Langner, MD

MD, Senior Scientist

Medical University of Graz

研究点 (1)

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