Assessment of the detection of neoplastic lesions in patients with longstanding ulcerative colitis, using different endoscopic imaging techniques: A: Chromo-endoscopy, methylene blue 0.1% (HDTV Olympus)B: HDTV Olympus colonoscopes and NBIC: Chromo-…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the difference between the three different
techniques in the detection of neoplastic lesions in patients with longstanding
ulcerative colitis.
Secondary outcome
Other end-points are: number of biopsies taken in the different groups, number
of detected neoplastic lesions for each technique, number of detected
non-neoplastic lesions for each technique, the total number of advanced adenoma
defined as adenoma with high grade dysplasia, villous components, intramucosal
carcinoma and angio-invasive growth, proportion of patients with low grade
adenoma, proportion of patients with high grade adenoma and the duration of
total endoscopic procedure time and of endoscopic procedure time during
retraction for each technique.
Background summary
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.
Study objective
Assessment of the detection of neoplastic lesions in patients with longstanding
ulcerative colitis, using different endoscopic imaging techniques:
A: Chromo-endoscopy, methylene blue 0.1% (HDTV Olympus)
B: HDTV Olympus colonoscopes and NBI
C: Chromo-endoscopy, methylene blue 0.1% (CCD Fujinon)
D: CCD Fujinon colonoscopes and FICE
E: Chromo-endoscopy, methylene blue 0.1% (HD Pentax)
F: HD Pentax colonoscopes and I-scan
Study design
a multi-center international prospective non-blinded randomized trial
Intervention
Screening colonoscopy for ulcerative colitis with different types of
colonoscopes and different endoscopic imaging techniques:
Group A: Chromo-endoscopy, methylene blue 0.1% (HDTV Olympus)
Group B: HDTV Olympus colonoscopes and NBI
Group C: Chromo-endoscopy, methylene blue 0.1% (CCD Fujinon)
Group D: CCD Fujinon colonoscopes and FICE
Group E: Chromo-endoscopy, methylene blue 0.1% (HD Pentax)
Group F: HD Pentax colonoscopes and I-scan
Study burden and risks
Risks are associated with colonoscopy procedure, but not with the type of
endoscope or use of different endoscopic imaging techniques. No differences in
risks between the six study groups is expected or anticipated. Serious risks
are very rare in colonoscopy and when occurring, are especially related to
interventions during endoscopy (i.e. polypectomy). Risks of diagnostic
colonoscopy are significant bleeding in 0.005% and perforation in 0.001% of
subjects. However, significant complications of polypectomy are extremely rare.
Patients fear will not differ between groups because of blinding of the patient
with respect of treatment arm.
postbus 5800
6202 AZ Maastricht
NL
postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
Signed informed consent form
Patients with longstanding ulcerative colitis: at least 8 years after diagnosis or pancolitis and 10 years after diagnosis of left-sided colitis
Sex: both males and females
Age: above 18 years
Exclusion criteria
Active ulcerative colitis
Personal history of colorectal cancer
Allergy or intolerance to methylene blue
Refusing or incapable to agree with informed consent
Pregnant women
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL35347.068.11 |