Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Inflammatory Bowel Disease (IBD)

University of Erlangen-Nürnberg Medical School40 enrolled

Overview

Precise activity assessment of inflammatory bowel disease (IBD) is essential to determine the extent and severity of the disease for further specific therapy. Nevertheless, despite ongoing developments in the field of gastrointestinal endoscopy, the final diagnosis still relies on the interpretation of histopathological features of intestinal biopsies taken during the endoscopic examination. Recently, endocytoscopy (EC) was introduced as a new endoscopic imaging modality, enabling microscopic imaging within the mucosal layer of the gut at a magnification level of up to 1400-fold.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Crohn´s Disease Ulcerative Colitis

Interventions

EndocytoscopyDEVICE

Patients with Crohn's disease and ulcerative colitis who underwent colonoscopy are prospectively included in this study. Methylene blue or toluidine blue is topically applied to enable EC (XEC-120-U, Olympus, Tokyo, Japan). Data are digitally saved and analyzed independently from each other by two gastroenterologists and one pathologist who are blinded to clinical and endoscopic data.

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 * Patients with known Crohn´s disease or ulcerative colitis Exclusion Criteria: * Inability to provide written informed consent * Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s) * Impaired renal function (Creatinine \> 1.2 mg/dl) * Pregnancy or breast feeding * Active gastrointestinal bleeding * Known allergy to methylene blue or toluidine blue * Residing in institutions (e.g. prison)

Outcomes

Primary Outcomes

To investigate the potential of endocytoscopy for in vivo detection of mucosal inflammatory cells.

Time frame: 40 patients

Secondary Outcomes

To evaluate the potential of endocytoscopy for the determination of intestinal inflammatory activity in patients with quiescent IBD and to compare endocytoscopy results with the results of standard histopathology