Endoscopic Screening for Dysplasia in Patients With Longstanding Ulcerative Colitis: Classical Chromo-endoscopy Versus NBI , FICE and EPK-i.

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
University Hospitals Leuven
RECRUITING
Leuven
H.-Hartziekenhuis Roeselare-Menen VZW
RECRUITING
Roeselaere
Canada
McGill University Health Center
RECRUITING
Montreal
Denmark
Copenhagen University Hospital Herlev
RECRUITING
Copenhagen
Netherlands
Academic Medical center Maastricht
RECRUITING
Maastricht
Contact Information
Primary
Vera Ballet
vera.ballet@uzleuven.be
+3216341601
Backup
Hilde Willekens
hilde.willekens@uzleuven.be
+3216340396
Time Frame
Start Date: 2008-05
Estimated Completion Date: 2027-11
Participants
Target number of participants: 402
Treatments
Active_comparator: OLYMPUS CHROMO
Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Experimental: OLYMPUS NBI
Group B: Virtual chromoendoscopy: HDTV Olympus colonoscopes and Narrow band Imaging (NBI)
Active_comparator: FUJINON CHROMO
Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Experimental: FUJINON FICE
Group D: Virtual chromoendoscopy: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement n° 4
Active_comparator: PENTAX CHROMO
Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Experimental: PENTX i-scan
Group F: Virtual chromoendoscopy: HD Pentax colonoscopes and I-scan 2 settings
Sponsors
Collaborators: McGill University, H.-Hartziekenhuis Roeselare-Menen VZW, Belgium., Copenhagen University Hospital at Herlev, Maastricht University Medical Center
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov