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临床试验/NCT03536091
NCT03536091已完成不适用

Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年3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
入组人数
80
试验地点
1
主要终点
Assessment of histopathological Inflammation

研究概览

简要总结

In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases (IBD).

详细描述

In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases. For this purpose, IBD patients will be prospectively enrolled and inflammatory changes will be assessed using optical magnification endoscopy in conjunction with optical chromoendoscopy. Endoscopic scoring of inflammatory changes in IBD patients will be done on a newly developed magnification score resulting as a consensus from experts in optical diagnosis and endoscopy in IBD patients. Results will be correlated against histopathology.

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
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with established diagnosis of Inflammatory Bowel Diseases
  • Ability to provide written informed consent
  • Age 18 years and older

排除标准

  • poor bowel preparation
  • inability to provide written informed consent

结局指标

主要结局

Assessment of histopathological Inflammation

时间窗: 12 months

Histopathologic Inflammation will be assessed by grading inflammation of intestinal biopsies routinely obtained during colonoscopy on established pathological scores.

Assessment of endoscopic Inflammation

时间窗: 12 months

Endoscopic Inflammation will be determined and scored by assessement of the vascular and mucosal pattern under magnification endoscopy.

次要结局

未报告次要终点

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Timo Rath

Professor of Endoscopy and Molecular Imaging

University of Erlangen-Nürnberg Medical School

研究点 (1)

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