Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)

Study Overview
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Brief Summary
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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 endoscopic and endomicroscopic features of mucosal healing in patients with IBD.

Conditions
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Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease

Intervention / Treatment
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* Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)
* Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
* Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)
* Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn's disease (CD)<br>Patients with CD and mucosal healing on endoscopy. | Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)<br>* Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.<br>|
| Crohn's disease<br>Patients with CD and mucosal healing on endomicroscopy. | Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)<br>* Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.<br>|
| Ulcerative colitis (UC)<br>Patients with UC and mucosal healing on endoscopy. | Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)<br>* Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.<br>|
| Ulcerative colitis<br>Patients with UC and mucosal healing on endomicroscopy. | Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)<br>* Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing | We will determine endoscopic (e.g. ulcera, erythema) and endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to define new criteria of mucosal healing and to define factors of disease remission and relapse. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic correlation | Comparison of clinical and histopathological data with endoscopic and endomicroscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD. | 3 years | 
| Therapeutic effect | We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment, corticosteroids) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage) and remission and relapse rate. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucosal healing