Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

Completed

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT03536091
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-05-24
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• poor bowel preparation
• inability to provide written informed consent
• minors

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of histopathological Inflammation	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	12 months	Endoscopic Inflammation will be determined and scored by assessement of the vascular and mucosal pattern under magnification endoscopy.

Trial Locations

Locations (1)

University Hospital Erlangen; 🇩🇪 Erlangen, Germany