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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
Helmut Neumann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01524120
First received: January 23, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mucosal healing [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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:
  • Histologic correlation [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.

  • Therapeutic effect [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 96
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  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. 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
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: 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-Nuremberg
Principal Investigator: Helmut Neumann, M.D., Ph.D. University of Erlangen-Nuremberg
  More Information

No publications provided

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01524120     History of Changes
Other Study ID Numbers: HN-0009
Study First Received: January 23, 2012
Last Updated: January 23, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014