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

University of Erlangen-Nürnberg Medical School

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

Interventions

Endoscopy (EPK-i, Pentax, Tokyo, Japan)DEVICE

Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.

Endomicroscopy (iCLE, Pentax, Tokyo, Japan)DEVICE

Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.

Endoscopy (EPK-i, Pentax, Tokyo, Japan)DEVICE

Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Erlangen-Nuremberg

Erlangen, Germany

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 3 years

Data from ClinicalTrials.gov

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