Endomicroscopy and Crohn´s Disease

This study has been completed.
Sponsor:
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01102855
First received: April 12, 2010
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

Purpose:

The main objective of this study is to determine endomicroscopic features of Crohn´s disease.

Background:

Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

Scope:

In patients with Crohn´s disease.


Condition
Crohn´s Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy in Patients With Crohn´s Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine endomicroscopic features of Crohn´s disease. [ Time Frame: October 2009 until May 2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of CLE findings with conventional histology. [ Time Frame: October 2009 until May 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Methods:

Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.

Procedure:

The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.

  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.

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

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 fluorescein, acriflavin or cresyl violet
  • Residing in institutions (e.g. prison)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102855

Locations
Germany
Department of Medicine I, University of Erlangen-Nuremberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Study Director: Markus F. Neurath 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: NCT01102855     History of Changes
Other Study ID Numbers: HN-0002
Study First Received: April 12, 2010
Last Updated: August 10, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014