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

NCT01289366 | Completed DMC

• 2 other identifiers: HN-0006Ecy1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To investigate the potential of endocytoscopy for in vivo detection of mucosal inflammatory cells.

  40 patients

Secondary Outcomes (1)

• 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

Study Arms (1)

Patients with IBD

Device: Endocytoscopy

Interventions

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.

Patients with IBD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Crohn's disease and ulcerative colitis who underwent colonoscopy.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (1)

• 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.

  PMID: 22644957 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Helmut Neumann, M.D., Ph.D.

  University of Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 3, 2011
• Study Start: May 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 11, 2011

Record last verified: 2011-08

Locations

DE (1)