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Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)

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ClinicalTrials.gov Identifier: NCT01524120
Recruitment Status : Unknown
Verified January 2013 by Helmut Neumann, University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Not yet recruiting
First Posted : February 1, 2012
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Helmut Neumann, University of Erlangen-Nürnberg Medical School

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns 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.

The main objective of this study is to determine endoscopic and endomicroscopic features of mucosal healing in patients with IBD.


Condition or disease Intervention/treatment
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan) Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)

Study Design
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Study Type : Observational
Estimated Enrollment : 96 participants
Time Perspective: Prospective
Study Start Date : April 2012
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Crohn's disease (CD)
Patients with CD and mucosal healing on endoscopy.
 Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)
Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Crohn's disease
Patients with CD and mucosal healing on endomicroscopy.
 Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
Ulcerative colitis (UC)
Patients with UC and mucosal healing on endoscopy.
 Device: Endoscopy (EPK-i, Pentax, Tokyo, Japan)
Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
Ulcerative colitis
Patients with UC and mucosal healing on endomicroscopy.
 Device: Endomicroscopy (iCLE, Pentax, Tokyo, Japan)
Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mucosal healing [ Time Frame: 3 years ]
    We will determine endoscopic (e.g. ulcera, erythema) and endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to define new criteria of mucosal healing and to define factors of disease remission and relapse.


Secondary Outcome Measures :
  1. Histologic correlation [ Time Frame: 3 years ]
    Comparison of clinical and histopathological data with endoscopic and endomicroscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.

  2. Therapeutic effect [ Time Frame: 3 years ]
    We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment, corticosteroids) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage) and remission and relapse rate.


Biospecimen Retention:   Samples With DNA
Biopsies were taken from every patient for subsequent histological analysis.

Eligibility Criteria
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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. Only patients with mucosal healing are included.
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)
  • Pregnancy or breast feeding
  • Active gastrointestinal bleeding
  • Residing in institutions (e.g. prison)
  • Known allergy against fluorescein
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01524120


Contacts
Contact: Markus F. Neurath, M.D., Ph.D. +49 9131 85-35000 markus.neurath@uk-erlangen.de

Locations
Germany
University of Erlangen-Nuremberg Not yet recruiting
Erlangen, Germany, 91054
Contact: Helmut Neumann, M.D., Ph.D.    +49 9131 85-35000    helmut.neumann@uk-erlangen.de   
Principal Investigator: Helmut Neumann, M.D., Ph.D.         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Markus F. Neurath, M.D., Ph.D. University of Erlangen-Nürnberg
Principal Investigator: Helmut Neumann, M.D., Ph.D. University of Erlangen-Nürnberg
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01524120     History of Changes
Other Study ID Numbers: HN-0009
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Helmut Neumann, University of Erlangen-Nürnberg Medical School:
Mucosal healing

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