CLE for Differential Diagnosis of IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-09-30

Brief Summary

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Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Ulcerative colitis

Endomicroscopy

Intervention Type DEVICE

Crohn's disease

Endomicroscopy

Intervention Type DEVICE

Interventions

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Endomicroscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* equal or above 18 years of age
* ability to provide written informed consent
* well-established diagnosis of CD or UC

Exclusion Criteria

* history of IBD reclassification in the last 3 years
* Boston Bowel Preparation Scale score's \< 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
* inability to provide written informed consent
* severe uncontrolled coagulopathy
* impaired renal function
* pregnancy or breast feeding
* active gastrointestinal bleeding
* known allergy to fluorescein
* residence in institutions

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No