Endomicroscopy for Assessment of Mucosal Healing

Study 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.

Official Title
-----------------
Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD

Conditions
-----------------
Crohn´s Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Device: Endomicroscopy


Participation Criteria
=================
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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn´s disease - active<br>Patients with Crohn´s disease in the active phase. | Device: Endomicroscopy<br>* Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.<br>|
| Crohn´s disease - quiescent<br>Patients with Crohn´s disease in the quiescent phase. | Device: Endomicroscopy<br>* Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.<br>|
| Ulcerative colitis - active<br>Patients with ulcerative colitis in the active stage. | Device: Endomicroscopy<br>* Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.<br>|
| Ucerative colitis - quiescent<br>Patients with ulcerative colitis in the quiescent stage. | Device: Endomicroscopy<br>* Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing | 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. | up to three years | 

Secondary Outcome Measures

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