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

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Colonoscopy Crohn's Disease

U.S. FDA Resources

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

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

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:

Kiesslich R, Duckworth CA, Moussata D, Gloeckner A, Lim LG, Goetz M, Pritchard DM, Galle PR, Neurath MF, Watson AJ. Local barrier dysfunction identified by confocal laser endomicroscopy predicts relapse in inflammatory bowel disease. Gut. 2012 Aug;61(8):1146-53. Epub 2011 Nov 24.

Liu JJ, Wong K, Thiesen AL, Mah SJ, Dieleman LA, Claggett B, Saltzman JR, Fedorak RN. Increased epithelial gaps in the small intestines of patients with inflammatory bowel disease: density matters. Gastrointest Endosc. 2011 Jun;73(6):1174-80. Epub 2011 Mar 11.

Li CQ, Xie XJ, Yu T, Gu XM, Zuo XL, Zhou CJ, Huang WQ, Chen H, Li YQ. Classification of inflammation activity in ulcerative colitis by confocal laser endomicroscopy. Am J Gastroenterol. 2010 Jun;105(6):1391-6. Epub 2009 Nov 24.

Vermeire S, Schreiber S, Sandborn WJ, Dubois C, Rutgeerts P. Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity. Clin Gastroenterol Hepatol. 2010 Apr;8(4):357-63. Epub 2010 Jan 21.

Van Assche G, Dignass A, Reinisch W, van der Woude CJ, Sturm A, De Vos M, Guslandi M, Oldenburg B, Dotan I, Marteau P, Ardizzone A, Baumgart DC, D'Haens G, Gionchetti P, Portela F, Vucelic B, Söderholm J, Escher J, Koletzko S, Kolho KL, Lukas M, Mottet C, Tilg H, Vermeire S, Carbonnel F, Cole A, Novacek G, Reinshagen M, Tsianos E, Herrlinger K, Oldenburg B, Bouhnik Y, Kiesslich R, Stange E, Travis S, Lindsay J; European Crohn's and Colitis Organisation (ECCO). The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Special situations. J Crohns Colitis. 2010 Feb;4(1):63-101. Epub 2009 Dec 21.

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 May 16, 2013