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.

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Key information

Conditions

Crohn´s Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Endocytoscopy

Device

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.

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

Time frame: 40 patients

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Patients With Inflammatory Bowel Disease

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Feb 3, 2011
Registry last updated: Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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