We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01289366
First Posted: February 3, 2011
Last Update Posted: August 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Erlangen-Nürnberg Medical School
  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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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-Nürnberg
  More Information

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
First Submitted: February 2, 2011
First Posted: February 3, 2011
Last Update Posted: August 11, 2011
Last Verified: August 2011

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