Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Inflammatory Bowel Disease (IBD)
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 Design:||Time Perspective: Prospective|
|Official Title:||Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Patients With Inflammatory Bowel Disease|
- To investigate the potential of endocytoscopy for in vivo detection of mucosal inflammatory cells. [ Time Frame: 40 patients ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: 40 patients ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Patients with IBD||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289366
|University of Erlangen-Nuremberg|
|Erlangen, Bayern, Germany, 91054|
|Principal Investigator:||Helmut Neumann, M.D., Ph.D.||University of Erlangen-Nuremberg|