Comparison Between Chromoendoscopy and Virtual Chromoendoscopy (NBI, I-scan, FICE) for Detection of Neoplasia in Long Standing Ulcerative Colitis
Endoscopic Screening for Dysplasia in Patients With Longstanding Ulcerative Colitis: Classical Chromo-endoscopy Versus NBI , FICE and EPK-i.
1 other identifier
interventional
402
4 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2008
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
ExpectedJuly 10, 2024
July 1, 2024
10.6 years
June 12, 2013
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The difference in total number of neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy
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.
The primary endpoint can be assessed when pathology results are available : 2 weeks after endoscopy
Secondary Outcomes (3)
Duration of total endoscopic procedure time and of endoscopic procedure time during retraction for each technique.
The endpoint can be assessed immediately after the endoscopy.
The difference in neoplasia detection rate (i.e. the number of patients with at least one neoplastic lesion) between chromoendoscopy and virtual chromoendoscopy.
The endpoint can be assessed when pathology results are available : 2 weeks after endoscopy
The difference in the ratio number of neoplastic lesions/ total number of lesions between chromoendoscopy and virtual chromoendoscopy
The endpoint can be assessed when pathology results are available : 2 weeks after endoscopy
Other Outcomes (2)
The difference in total number of non-neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy
The endpoint can be assessed when pathology results are available : 2 weeks after endoscopy
Number of biopsies per colonoscopy taken in the different groups.
Endpoint can be assessed immediately after endoscopy
Study Arms (6)
OLYMPUS CHROMO
ACTIVE COMPARATORGroup A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1%
OLYMPUS NBI
EXPERIMENTALGroup B: Virtual chromoendoscopy: HDTV Olympus colonoscopes and Narrow band Imaging (NBI)
FUJINON CHROMO
ACTIVE COMPARATORGroup C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1%
FUJINON FICE
EXPERIMENTALGroup D: Virtual chromoendoscopy: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement n° 4
PENTAX CHROMO
ACTIVE COMPARATORGroup E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1%
PENTX i-scan
EXPERIMENTALGroup F: Virtual chromoendoscopy: HD Pentax colonoscopes and I-scan 2 settings
Interventions
Panchromocolonoscopy with methyleen blue 0.1%
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- H.-Hartziekenhuis Roeselare-Menen VZW, Belgium.collaborator
- McGill Universitycollaborator
- Maastricht University Medical Centercollaborator
- Copenhagen University Hospital at Herlevcollaborator
Study Sites (5)
University Hospitals Leuven
Leuven, 3000, Belgium
H.-Hartziekenhuis Roeselare-Menen VZW
Roeselaere, 8800, Belgium
McGill University Health Center
Montreal, Canada
Copenhagen University Hospital Herlev
Copenhagen, 2730, Denmark
Academic Medical center Maastricht
Maastricht, 6219 NG, Netherlands
Related Publications (2)
Bisschops R, Bessissow T, Dekker E, East JE, Para-Blanco A, Ragunath K, Bhandari P, Rutter M, Schoon E, Wilson A, John JM, Van Steen K, Baert F, Ferrante M. Pit pattern analysis with high-definition chromoendoscopy and narrow-band imaging for optical diagnosis of dysplasia in patients with ulcerative colitis. Gastrointest Endosc. 2017 Dec;86(6):1100-1106.e1. doi: 10.1016/j.gie.2017.09.024. Epub 2017 Oct 3.
PMID: 28986266DERIVEDBisschops R, Bessissow T, Joseph JA, Baert F, Ferrante M, Ballet V, Willekens H, Demedts I, Geboes K, De Hertogh G, Vermeire S, Rutgeerts P, Van Assche G. Chromoendoscopy versus narrow band imaging in UC: a prospective randomised controlled trial. Gut. 2018 Jun;67(6):1087-1094. doi: 10.1136/gutjnl-2016-313213. Epub 2017 Jul 11.
PMID: 28698230DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raf Bisschops, MD PhD
Universitaire Ziekenhuizen KU Leuven
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 20, 2013
Study Start
May 1, 2008
Primary Completion
December 1, 2018
Study Completion (Estimated)
November 1, 2027
Last Updated
July 10, 2024
Record last verified: 2024-07