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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289366
• Other study ID #: HN-0006
• Secondary ID: Ecy1
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: August 10, 2011
• Start date: May 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn´s Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Device:
• Endocytoscopy
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.

Locations

Country	Name	City	State
Germany	University of Erlangen-Nuremberg	Erlangen	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the potential of endocytoscopy for in vivo detection of mucosal inflammatory cells.		40 patients	Yes
Secondary	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	Yes