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

Completed

• Conditions: Crohn´s Disease; Ulcerative Colitis
• Interventions: Device: Endocytoscopy

• Registration Number: NCT01289366
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with IBD	Endocytoscopy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Erlangen-Nuremberg; 🇩🇪 Erlangen, Bayern, Germany