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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01289366

Enrollment

Registered

2011-02-03

Start date

2010-05-31

Completion date

2011-08-31

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn´s Disease, Ulcerative Colitis

Brief 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.

Interventions

DEVICEEndocytoscopy

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.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
To investigate the potential of endocytoscopy for in vivo detection of mucosal inflammatory cells.	40 patients

Secondary

Measure	Time frame
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	40 patients

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026