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

This study has been completed.
Sponsor:
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01289366
First received: February 2, 2011
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Crohn´s Disease
Ulcerative Colitis
Device: Endocytoscopy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Patients With Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • To investigate the potential of endocytoscopy for in vivo detection of mucosal inflammatory cells. [ Time Frame: 40 patients ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 40 patients ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with IBD 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289366

Locations
Germany
University of Erlangen-Nuremberg
Erlangen, Bayern, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Helmut Neumann, M.D., Ph.D. University of Erlangen-Nuremberg
  More Information

No publications provided by University of Erlangen-Nürnberg Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markus F. Neurath, M.D., Ph.D., University of Erlangen-Nuremberg
ClinicalTrials.gov Identifier: NCT01289366     History of Changes
Other Study ID Numbers: HN-0006, Ecy1
Study First Received: February 2, 2011
Last Updated: August 10, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014