Characterization of Crohn's Disease at Confocal Laser Endomicroscopy (CLE) and Related to Disease Activity

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
John Gasdal Karstensen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01738529
First received: November 19, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy (CLE) together with standard white light colonoscopy including inter- and intra-observation of patients with Crohn's disease.


Condition Intervention
Crohn Disease
Device: CLE ileocolonoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Characterization of Crohn's Disease at Confocal Laser Endomicroscopy and Related to Disease Activity

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • CLE (CLE score) vs WL colonoscopy (SES-CD) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Findings in CLE are recorded regarding inflammation (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion 1-3 points each) and compared with the findings of conventional colonoscopy ted Simple endoscopic score - Crohn´s disease (SES-CD), including observations for the control group

  • CLE (CLE-score) vs pathology score for inflammation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    CLE (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion 1-3 points each) and colonoscopy findings are compared with the pathological evaluation of the inflammation in the tissue samples (points from 1-3 by the severity).

  • CLE findings (CLE-score) and Intra-and inter-observer agreement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Intra-and inter-observer agreements between 3 operators at CLE findings are calculated by kappa statistics (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion).


Secondary Outcome Measures:
  • Registering time of the procedure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Registering time of the procedure.

  • Number of Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of Adverse Events related to the procedure is registered


Estimated Enrollment: 36
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CLE ileocolonoscopy on Crohn patients
Patients known with Crohn´s disease
Device: CLE ileocolonoscopy
The patients enrolled including the control group, will be investigated respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE (selected parameters) and histology biopsies. Then, the correlation between histology (gold standard), SI and CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3 observers are blinded with respect to each other. The pathologist is blinded to conventional and CLE parameters. CLE results are stratified in order to identify which of the recorded CLE parameters that correlate best with the two other methods.
Other Names:
  • confocal laser endomiscoscopy ileocolonoscopy
  • confocal laser endomiscoscopy colonoscopy
Sham Comparator: CLE ileocolonoscopy on control patients
CLE ileocolonoscopy on patients without known IBD
Device: CLE ileocolonoscopy
The patients enrolled including the control group, will be investigated respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE (selected parameters) and histology biopsies. Then, the correlation between histology (gold standard), SI and CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3 observers are blinded with respect to each other. The pathologist is blinded to conventional and CLE parameters. CLE results are stratified in order to identify which of the recorded CLE parameters that correlate best with the two other methods.
Other Names:
  • confocal laser endomiscoscopy ileocolonoscopy
  • confocal laser endomiscoscopy colonoscopy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with Crohn's disease and involvement of the ileum and / or colon
  • Patients must be of legal age
  • Shall be given written consent
  • Both patients with the activity of their disease patients in remission on biological treatment including can be included
  • The control group will consist of patients without known or suspected IBD

Exclusion Criteria:

  • Increased p-creatinine
  • Demonstrated allergy to fluorescein
  • Pregnant woman
  • Lactating woman
  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: NCT01738529

Contacts
Contact: John g Karstensen, M.D. +45 38681358 john.gasdal.karstensen.01@regionh.dk
Contact: Peter Vilmann, prof. + 45 61677950 peter.vilmann@regionh.dk

Locations
Denmark
Copenhagen University Hospital Herlev Recruiting
Herlev, Denmark, 2730
Contact: John g Karstensen, M.D.    +45 38681358    john.gasdal.karstensen.01@regionh.dk   
Contact: Peter Vilmann, prof.    +61677950    peter.vilmann@regionh.dk   
Principal Investigator: John g Karstensen, M.D.         
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: john g Karstensen, M.D. Department of Gastroenterology
Study Chair: peter vilmann, Prof. Department of Gastroenterology
  More Information

Publications:

Responsible Party: John Gasdal Karstensen, MD., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01738529     History of Changes
Other Study ID Numbers: H-1-2012-089 sub 3
Study First Received: November 19, 2012
Last Updated: November 29, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
confocal laser endomicroscopy
Crohn´disease

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

ClinicalTrials.gov processed this record on July 29, 2014