NCT01738529

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

1.9 years

First QC Date

November 19, 2012

Last Update Submit

February 17, 2015

Conditions

Crohn Disease

Keywords

confocal laser endomicroscopyCrohn´disease

Outcome Measures

Primary Outcomes (3)

  • CLE (CLE score) vs WL colonoscopy (SES-CD)

    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

    1 year

  • CLE (CLE-score) vs pathology score for inflammation

    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).

    1 year

  • CLE findings (CLE-score) and Intra-and inter-observer agreement

    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).

    1 year

Secondary Outcomes (2)

  • Registering time of the procedure.

    1 year

  • Number of Adverse Events

    1 year

Study Arms (2)

CLE ileocolonoscopy on Crohn patients

ACTIVE COMPARATOR

Patients known with Crohn´s disease

Device: CLE ileocolonoscopy

CLE ileocolonoscopy on control patients

SHAM COMPARATOR

CLE ileocolonoscopy on patients without known IBD

Device: CLE ileocolonoscopy

Interventions

CLE ileocolonoscopyDEVICE

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.

Also known as: confocal laser endomiscoscopy ileocolonoscopy, confocal laser endomiscoscopy colonoscopy
CLE ileocolonoscopy on Crohn patientsCLE ileocolonoscopy on control patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital Herlev

Herlev, 2730, Denmark

Location

Related Publications (6)

  • 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. doi: 10.1136/gutjnl-2011-300695. Epub 2011 Nov 24.

    PMID: 22115910BACKGROUND

  • 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. doi: 10.1016/j.gie.2011.01.018. Epub 2011 Mar 11.

    PMID: 21396639BACKGROUND

  • 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. doi: 10.1038/ajg.2009.664. Epub 2009 Nov 24.

    PMID: 19935787BACKGROUND

  • 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. doi: 10.1016/j.cgh.2010.01.001. Epub 2010 Jan 21.

    PMID: 20096379BACKGROUND

  • 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, Soderholm 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. doi: 10.1016/j.crohns.2009.09.009. Epub 2009 Dec 21. No abstract available.

    PMID: 21122490BACKGROUND

  • Karstensen JG, Saftoiu A, Brynskov J, Hendel J, Klausen P, Cartana T, Klausen TW, Riis LB, Vilmann P. Confocal laser endomicroscopy: a novel method for prediction of relapse in Crohn's disease. Endoscopy. 2016 Apr;48(4):364-72. doi: 10.1055/s-0034-1393314. Epub 2015 Nov 19.

    PMID: 26583952DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • john g Karstensen, M.D.

    Department of Gastroenterology

    PRINCIPAL INVESTIGATOR

  • peter vilmann, Prof.

    Department of Gastroenterology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 30, 2012

Study Start

November 1, 2012

Primary Completion

October 1, 2014

Study Completion

February 1, 2015

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

DK(1)