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Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882205
Recruitment Status : Unknown
Verified July 2017 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : June 20, 2013
Last Update Posted : July 26, 2017
Sponsor:
Collaborators:
H.-Hartziekenhuis Roeselare-Menen VZW, Belgium.
McGill University
Maastricht University Medical Center
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a surveillance program eight years after the diagnosis. Until today, official international guidelines for endoscopic screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely based on consensus during expert opinion meetings rather than evidence based. Recent studies have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies for each procedure and detected more neoplastic lesions. Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic imaging techniques.

Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. The first studies with NBI showed that the additional value of NBI in the detection of neoplastic lesions is comparable to chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is achieved via the use of post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-scan system also allows post hoc modification of the images. On the one hand, surface enhancement enables to better highlight mucosal changes. Spectral modification allows to apply different modes in analogy with to FICE system.

These new imaging techniques have a theoretical advantage which is extendedly used for sales purposes but has however so far not been proven in ulcerative colitis patients. We want to test their clinical use in the screening for neoplastic lesions in patients with long standing ulcerative colitis.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: Virtual chromoendoscopy Procedure: Chromoendoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Endoscopic Screening for Dysplasia in Patients With Longstanding Ulcerative Colitis: Classical Chromo-endoscopy Versus NBI , FICE and EPK-i.
Study Start Date : May 2008
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: OLYMPUS CHROMO
Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Procedure: Chromoendoscopy
Panchromocolonoscopy with methyleen blue 0.1%

Experimental: OLYMPUS NBI
Group B: Virtual chromoendoscopy: HDTV Olympus colonoscopes and Narrow band Imaging (NBI)
Device: Virtual chromoendoscopy
Other Names:
  • Narrow band Imaging (NBI)
  • Fujinon Intelligent Color Enhancement
  • I-scan

Active Comparator: FUJINON CHROMO
Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Procedure: Chromoendoscopy
Panchromocolonoscopy with methyleen blue 0.1%

Experimental: FUJINON FICE
Group D: Virtual chromoendoscopy: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement n° 4
Device: Virtual chromoendoscopy
Other Names:
  • Narrow band Imaging (NBI)
  • Fujinon Intelligent Color Enhancement
  • I-scan

Active Comparator: PENTAX CHROMO
Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Procedure: Chromoendoscopy
Panchromocolonoscopy with methyleen blue 0.1%

Experimental: PENTX i-scan
Group F: Virtual chromoendoscopy: HD Pentax colonoscopes and I-scan 2 settings
Device: Virtual chromoendoscopy
Other Names:
  • Narrow band Imaging (NBI)
  • Fujinon Intelligent Color Enhancement
  • I-scan




Primary Outcome Measures :
  1. The difference in total number of neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy [ Time Frame: The primary endpoint can be assessed when pathology results are available : 2 weeks after endoscopy ]

    The primary endpoint will be assessed in three subgroups comparing :

    1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI)

    2) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement

    3) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan

    As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.



Secondary Outcome Measures :
  1. Duration of total endoscopic procedure time and of endoscopic procedure time during retraction for each technique. [ Time Frame: The endpoint can be assessed immediately after the endoscopy. ]
    The total endoscopy time is recorded from the start until the end of the entire procedure. After the caecum is reached, time is recorded. Total retraction time is the time between reaching the caecum and the end of the procedure and includes time for rinsing, dye spraying, biopsy or poliepectomy.

  2. The difference in neoplasia detection rate (i.e. the number of patients with at least one neoplastic lesion) between chromoendoscopy and virtual chromoendoscopy. [ Time Frame: The endpoint can be assessed when pathology results are available : 2 weeks after endoscopy ]

    The endpoint will be assessed in three subgroups comparing :

    1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI) 2) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement 3) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.


  3. The difference in the ratio number of neoplastic lesions/ total number of lesions between chromoendoscopy and virtual chromoendoscopy [ Time Frame: The endpoint can be assessed when pathology results are available : 2 weeks after endoscopy ]

    The endpoint will be assessed in three subgroups comparing :

    1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI) 2) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement 3) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.



Other Outcome Measures:
  1. The difference in total number of non-neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy [ Time Frame: The endpoint can be assessed when pathology results are available : 2 weeks after endoscopy ]

    The endpoint will be assessed in three subgroups comparing :

    1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI) 2) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement 3) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.


  2. Number of biopsies per colonoscopy taken in the different groups. [ Time Frame: Endpoint can be assessed immediately after endoscopy ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with longstanding ulcerative colitis ( 8 years after diagnosis or pancolitis and 10 years after diagnosis of left-sided colitis)
  • Signed informed consent form
  • Previous surveillance endoscopy > 1 year

Exclusion Criteria:

  • Active ulcerative colitis, > 20 cm from the margo ani
  • Personal history of colorectal cancer
  • Allergy or intolerance to methylene blue
  • Refusing or incapable to agree with informed consent
  • Age younger than 18 years
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882205


Contacts
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Contact: Vera Ballet +3216341601 vera.ballet@uzleuven.be
Contact: Hilde Willekens +3216340396 hilde.willekens@uzleuven.be

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Raf Bisschops, MD PhD    +3216344225    raf.bisschops@uzleuven.be   
Contact: Marc Ferrante, MD PhD    +3216344225    ùarc.ferrante@uzleuven.be   
Principal Investigator: Raf Bisschops, PD PhD         
Sub-Investigator: Gert Van Assche, MD PhD         
Sub-Investigator: Ingrid Demedts, Md PhD         
Sub-Investigator: Paul Rutgeerts, MD PhD         
H.-Hartziekenhuis Roeselare-Menen VZW Recruiting
Roeselaere, Belgium, 8800
Contact: Filip Baert, MD    +32515372    mailto:fbaert@hhr.be   
Principal Investigator: Filip Baert, MD PhD         
Canada
McGill University Health Center Recruiting
Montreal, Canada
Contact: Talat Bessissow, MD PhD    +15145017799    talat.bessissow@gmail.com   
Principal Investigator: Talat Bessissow, MD PhD         
Denmark
Copenhagen University Hospital Herlev Recruiting
Copenhagen, Denmark, 2730
Contact: John Gasdal Karstensen, MD    +4538681358    john.gasdal.karstensen.01@regionh.dk   
Principal Investigator: Jakob Hendel, MD PhD         
Sub-Investigator: John Gasdal Karstensen, MD         
Netherlands
Academic Medical center Maastricht Recruiting
Maastricht, Netherlands, 6219 NG
Contact: Rogier De Ridder, MD    +31433876543    r.de.ridder@mumc.nl   
Principal Investigator: Rogier De Ridder, MD         
Sub-Investigator: Marie Pierik, MC PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
H.-Hartziekenhuis Roeselare-Menen VZW, Belgium.
McGill University
Maastricht University Medical Center
Copenhagen University Hospital at Herlev
Investigators
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Principal Investigator: Raf Bisschops, MD PhD Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01882205    
Other Study ID Numbers: S50565
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Keywords provided by Universitaire Ziekenhuizen Leuven:
Ulcerative colitis
DALM
chromoendoscopy
dysplasia
virtual chromoendoscopy
FICE
NBI
I-scan
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases