Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn´s Disease
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Mucosal healing
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
The main objective of this study is to determine endomicroscopic features of mucosal healing in patients with IBD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •Age 18-85 years
- •Ability of subjects to understand character and individual consequences of clinical trial
- •Subjects undergoing colonoscopy
Exclusion Criteria
- •Inability to provide written informed consent
- •Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
- •Pregnancy or breast feeding
- •Active gastrointestinal bleeding
- •Residing in institutions (e.g. prison)
- •Known allergy against fluorescein
- •Proctocolectomy
Outcomes
Primary Outcomes
Mucosal healing
Time Frame: up to three years
We will determine endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing.
Secondary Outcomes
- Histologic correlation(up to three years)
- Therapeutic effect(up to three years)