Confocal Laser Endomicroscopy Findings in Patients With Proctosigmoiditis Before and After Initiation of Treatment

NCT01684514 | Completed DMC

• 1 other identifier: H-1-2012-089 sub-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Confocal laser endomicroscopy (CLE) is a novel method in evaluation of microscopic structures in vivo. The examination is carried out with a confocal laser endomicroscope, which is either part of the endoscope (manufactured by Pentax) or probe based (manufactured by Cellvizio). Hereby, all parts of the gastrointestinal (GI) tract can be examined. The method has potential to replace conventional microscopy and the dynamic nature of the procedure allows visualization of structures and cellular processes in almost real-time. This provides us with a potentially new diagnostic tool with a promising future. To date only a few studies have been published on inflammatory bowel disease (IBD) and in the literature high-quality research is still lacking. The project consists of a blinded prospective observation and methodology study including inter- and intra-observation of patients with proctitis before and after initiation of local treatment. Hypothesis: CLE can be used to assess the degree and extend of acute and chronic inflammation and treatment response in patients with ulcerative colitis and is a sensitive supplementary to conventional diagnostics.

Conditions

Colitis, Ulcerative

Keywords

confocal laser endomicroscopy; inflammatory bowel disease; colitis, ulcerative

Outcome Measures

Primary Outcomes (3)

• CLE findings are recorded and compared with the findings of conventional colonoscopy (Mayo score), including observations for the control group

  The trial will go on for 2 years

• CLE and colonoscopy findings are compared with the pathological evaluation of tissue samples.

  The trial will go on for 2 years

• Intra-and inter-observer agreement between 3 CLE operators is calculated by kappa statistics

  The trial will go on for 2 years

Secondary Outcomes (3)

• Effect of therapy with topical therapy, based on the results of the conventional colonoscopy and CLE

  The trial will go on for 2 years

• Registering time of the procedure.

  The trial will go on for 2 years

• Registering possible complications

  The trial will go on for 2 years

Study Arms (2)

colitis, ulcerative

EXPERIMENTAL

Enrolled patients will be examined by conventional colonoscopy and confocal laser endomicroscopy before and after initiation of topical treatment, respectively.

Device: Confocal laser endomicroscopy

Control group

SHAM COMPARATOR

A control group will be examined by conventional colonoscopy and confocal laser endomicroscopy.

Device: Confocal laser endomicroscopy

Interventions

Confocal laser endomicroscopy DEVICE

Within recent years a new approach was introduced, wherein the microscopic structures of the intestinal mucous can be evaluated continuously in vivo during the endoscopic procedure. The technique is called confocal laser endomicroscopy (CLE). CLE functions by means of a laser device, which is inserted or build into an endoscope, and used as an illuminator of the lining of a small area and at a precise depth. The tissue is first added with fluorescence by intravenous administration. The reflection of the mucosa is captured in a focused area and magnified by which a two-dimensional image of mucosal microscopic structures is formed. This provides us with an "optical biopsy", which can be compared with a similar microscopic image.

Control group; colitis, ulcerative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with active proctitis or proctosigmoiditis due to ulcerative colitis, where an indication for treatment and colonoscopy exists. Newly diagnosed as well as patients already in oral 5-ASA therapy, may be included.
• The control group will consist of patients without known or suspected IBD. Patients must be of legal age. Patients who have received written informed consent.

You may not qualify if:

• Increased p-creatinine and/or demonstrated allergy to fluorescein. Pregnant and lactating women. Ongoing systemic immunosuppressive therapy with prednisolone, azathioprine or biological agents.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (2)

John Gásdal Karstensen

Birkerød, 3460, Denmark

Location

Gastroenheden, Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (14)

• Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.

  PMID: 3317057 BACKGROUND

• Riley SA, Mani V, Goodman MJ, Dutt S, Herd ME. Microscopic activity in ulcerative colitis: what does it mean? Gut. 1991 Feb;32(2):174-8. doi: 10.1136/gut.32.2.174.

  PMID: 1864537 BACKGROUND

• 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: 19935787 BACKGROUND

• Wu K, Liu JJ, Adams W, Sonn GA, Mach KE, Pan Y, Beck AH, Jensen KC, Liao JC. Dynamic real-time microscopy of the urinary tract using confocal laser endomicroscopy. Urology. 2011 Jul;78(1):225-31. doi: 10.1016/j.urology.2011.02.057. Epub 2011 May 23.

  PMID: 21601243 BACKGROUND

• Kiesslich R, Goetz M, Neurath MF. Confocal laser endomicroscopy for gastrointestinal diseases. Gastrointest Endosc Clin N Am. 2008 Jul;18(3):451-66, viii. doi: 10.1016/j.giec.2008.03.002.

  PMID: 18674696 BACKGROUND

• Fuchs FS, Zirlik S, Hildner K, Frieser M, Ganslmayer M, Schwarz S, Uder M, Neurath MF. Fluorescein-aided confocal laser endomicroscopy of the lung. Respiration. 2011;81(1):32-8. doi: 10.1159/000320365. Epub 2010 Aug 21.

  PMID: 20733287 BACKGROUND

• 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: 21396639 BACKGROUND

• 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: 22115910 BACKGROUND

• Wyatt J, Vogelsang H, Hubl W, Waldhoer T, Lochs H. Intestinal permeability and the prediction of relapse in Crohn's disease. Lancet. 1993 Jun 5;341(8858):1437-9. doi: 10.1016/0140-6736(93)90882-h.

  PMID: 8099141 BACKGROUND

• Peeters M, Ghoos Y, Maes B, Hiele M, Geboes K, Vantrappen G, Rutgeerts P. Increased permeability of macroscopically normal small bowel in Crohn's disease. Dig Dis Sci. 1994 Oct;39(10):2170-6. doi: 10.1007/BF02090367.

  PMID: 7924738 BACKGROUND

• Gheorghe C, Cotruta B, Iacob R, Becheanu G, Dumbrava M, Gheorghe L. Endomicroscopy for assessing mucosal healing in patients with ulcerative colitis. J Gastrointestin Liver Dis. 2011 Dec;20(4):423-6.

  PMID: 22187709 BACKGROUND

• Wang TD. Confocal microscopy from the bench to the bedside. Gastrointest Endosc. 2005 Nov;62(5):696-7. doi: 10.1016/j.gie.2005.06.002. No abstract available.

  PMID: 16246681 BACKGROUND

• Kiesslich R, Goetz M, Lammersdorf K, Schneider C, Burg J, Stolte M, Vieth M, Nafe B, Galle PR, Neurath MF. Chromoscopy-guided endomicroscopy increases the diagnostic yield of intraepithelial neoplasia in ulcerative colitis. Gastroenterology. 2007 Mar;132(3):874-82. doi: 10.1053/j.gastro.2007.01.048. Epub 2007 Jan 31.

  PMID: 17383417 BACKGROUND

• Karstensen JG, Saftoiu A, Brynskov J, Hendel J, Ciocalteu A, Klausen P, Klausen TW, Riis LB, Vilmann P. Confocal laser endomicroscopy in ulcerative colitis: a longitudinal study of endomicroscopic changes and response to medical therapy (with videos). Gastrointest Endosc. 2016 Aug;84(2):279-286.e1. doi: 10.1016/j.gie.2016.01.069. Epub 2016 Mar 2.

  PMID: 26945556 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• John G Karstensen, MD

  Gastroenheden, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, ph.d.-student

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 13, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

DK (2)