Recruiting

Chromoendoscopy & Virtual Chromoendoscopy

Sponsor:

Universitaire Ziekenhuizen KU Leuven

Code:

NCT01882205

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual chromoendoscopy

Chromoendoscopy

Study Details

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.

Conditions

Ulcerative Colitis

Study ID

NCT01882205

Start date

May, 2008

Status verified date

Jul, 2024

Completion date

Nov, 2027

Anticipated

Primary completion date

Dec, 2018

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

402 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

Virtual chromoendoscopy

Chromoendoscopy

Panchromocolonoscopy with methyleen blue 0.1%

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

McGill University Health Center

Recruiting

Montreal, Canada

Contacts

Principal Investigator:

Talat Bessissow, MD PhD

More Information

Sponsor

Universitaire Ziekenhuizen KU Leuven

Last update posted

Jul 10, 2024

Last verified

Jul, 2024

Keywords

  • Ulcerative colitis
  • DALM
  • chromoendoscopy
  • dysplasia
  • virtual chromoendoscopy
  • FICE
  • NBI
  • I-scan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven on 2024-07-10.