Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

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).

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Diagnostic test: Magnification endoscopy

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • University Hospital Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

IBD patients treated in the outpatient department of the University Hospital Erlangen

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of endoscopic Inflammation	Endoscopic Inflammation will be determined and scored by assessement of the vascular and mucosal pattern under magnification endoscopy.	12 months
Assessment of histopathological Inflammation	Histopathologic Inflammation will be assessed by grading inflammation of intestinal biopsies routinely obtained during colonoscopy on established pathological scores.	12 months

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: EREN IBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No