Endomicroscopy for Assessment of Mucosal Healing

This study is currently recruiting participants. (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:
NCT01417715
First received: August 10, 2011
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 endomicroscopic features of mucosal healing in patients with IBD.


Condition Intervention
Crohn´s Disease
Ulcerative Colitis
Device: Endomicroscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Advanced Endoscopic Imaging Using Endomicroscopy for Assessment of Mucosal Healing in IBD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mucosal healing [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
    We will determine endomicroscopic features of mucosal inflammation (e.g. goblet cell depletion, leackage, microvessel density) in IBD in order to establish a new endoscopic classification of mucosal healing.


Secondary Outcome Measures:
  • Histologic correlation [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
    Comparison of clinical and histopathological data with endoscopic findings to evaluate mucosal healing as a parameter of remission and relapse in patients with IBD.

  • Therapeutic effect [ Time Frame: up to three years ] [ Designated as safety issue: Yes ]
    We will evaluate the effect of different therapeutic strategies (eg. anti-TNF treatment) on characteristics of mucosal healing (e.g. goblet cell depletion, microvessels, leakage).


Estimated Enrollment: 84
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Crohn´s disease - active
Patients with Crohn´s disease in the active phase.
Device: Endomicroscopy
Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Crohn´s disease - quiescent
Patients with Crohn´s disease in the quiescent phase.
Device: Endomicroscopy
Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Ulcerative colitis - active
Patients with ulcerative colitis in the active stage.
Device: Endomicroscopy
Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
Ucerative colitis - quiescent
Patients with ulcerative colitis in the quiescent stage.
Device: Endomicroscopy
Patients will undergo advanced endoscopic imaging using endomicroscopy. 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:   Non-Probability Sample
Study Population

Patients with Crohn´s disease and ulcerative colitis in the active and quiescent phase of the 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)
  • Pregnancy or breast feeding
  • Active gastrointestinal bleeding
  • Residing in institutions (e.g. prison)
  • Known allergy against fluorescein
  • Proctocolectomy
  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: NCT01417715

Contacts
Contact: Helmut Neumann, Professor +4991318535000 helmut.neumann@uk-erlangen.de
Contact: Markus F. Neurath, Professor +4991318535000 markus.neurath@uk-erlangen.de

Locations
Germany
University of Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91054
Contact: Helmut Neumann, Professor    +4991318535000    helmut.neumann@uk-erlangen.de   
Principal Investigator: Helmut Neumann, Professor         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Helmut Neumann, Professor Department of Medicine I, University of Erlangen-Nuremberg, Germany
Principal Investigator: Markus F. Neurath, Professor Department of Medicine I, University of Erlangen-Nuremberg, Germany
  More Information

No publications provided

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01417715     History of Changes
Other Study ID Numbers: HN-0008
Study First Received: August 10, 2011
Last Updated: January 23, 2013
Health Authority: Germany: Ethik-Kommission

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

ClinicalTrials.gov processed this record on September 18, 2014