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

NCT ID: NCT01289366

Last Updated: 2011-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-08-31

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.

Conditions

Crohn´s Disease; Ulcerative Colitis

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with IBD

Endocytoscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

University of Erlangen-Nuremberg

Principal Investigators

Helmut Neumann, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nürnberg

Locations

University of Erlangen-Nuremberg

Erlangen, Bavaria, Germany

Countries

Germany

References

Neumann H, Vieth M, Neurath MF, Atreya R. Endocytoscopy allows accurate in vivo differentiation of mucosal inflammatory cells in IBD: a pilot study. Inflamm Bowel Dis. 2013 Feb;19(2):356-62. doi: 10.1002/ibd.23025.

Reference Type: DERIVED

PMID: 22644957 (View on PubMed)

Other Identifiers

Ecy1

Identifier Type: -

Identifier Source: secondary_id

HN-0006

Identifier Type: -

Identifier Source: org_study_id