CompletedNot Applicable

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

Germany40 participantsStarted 2010-05

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

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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 * 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)

What they're measuring

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

Timeframe: 40 patients

Trial details

NCT IDNCT01289366

SponsorUniversity of Erlangen-Nürnberg Medical School

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-08

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