Inflammatory Bowel Diseases, Colorectal Neoplasms
Conditions
Keywords
IBD, Inflammatory Bowel Diseases, Colorectal Cancer, Surveillance, Dysplasia, Back-to-Back, Chromoendoscopy, White light
Brief summary
The current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. However, data on the superiority of CE over HDWLE are not consistent in literature. The investigators hypothesize that the better performance of CE in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. Currently, no studies have been published evaluating the dysplastic yield of back-to back HDWLE compared to HDWLE with a single pass or CE in patients with IBD. In the present study, the investigators aim to compare the yield of dysplasia/CRC between 1) regular HDWLE, 2) HDWLE back-to-back, and 3) CE.
Detailed description
The investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (Imperatore et al 2019). To show non-inferiority of back-to-back HDWLE compared to CE, with a non-inferiority margin of 10% (power 80% and alpha 5%,) a total of 226 patients per group is required. To demonstrate a superiority of back-to-back HDWLE compared to a regular HDWLE, with a 1:2 allocation ratio of single-pass vs back-to-back , 113 and 226 patients per group are needed to achieve 80% power with an alpha of 5%. Therefore, the investigators will include 226 patients in group back-to-back HDWLE, 226 in group CE, and 113 patients in group regular HDWLE. This amounts to a total of 560 patients. To account for any screen-failures The investigators will include at most 5% (of 560) additional patients until 80% power is reached.
Interventions
PROCEDUREBack-to-back high-definition white light endoscopy
Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached, with a second segmental inspection after the first examination in the same session.The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.
PROCEDUREsingle-pass high-definition white light endoscopy
Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached. The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.
PROCEDUREchromoendoscopy
After introduction of the endoscope into the colon a dye (methylene blue or indigo carmine) will be sprayed through a catheter positioned into the biopsy channel. Per segment, the entire colon is dyed, inspected, and lesions are removed. Equipment is similar to the other two interventions.
Sponsors
UMC Utrecht
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a multicenter, non-blinded randomized trial with three parallel arms: back-to-back HDWLE, single-pass HDWLE and CE.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Patients with inflammatory bowel disease, an estimated involvement of at least 30% of the colonic surface and a disease duration of at least 8 years (or any disease duration in case of concomitant primary sclerosing cholangitis). * Previous assessable surveillance endoscopy \> 1 year * Age \> 18 years
Exclusion criteria
* Active colitis \> 20 cm and/or inflammation resulting in an insufficient surveillance procedure according to the endoscopist. * Allergy or intolerance to methylene blue * Insufficient bowel cleansing (BBPS \<6) * Refusing or incapable to agree with informed consent * Pregnant women * \> 50 % of the colon surgically removed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| detection rate of neoplasia for each technique | During endoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of dysplastic lesions for each technique | After each endoscopy, within one month after the procedure. | — |
| Kudo classification for each lesion | During endoscopy when a lesion is detected | — |
| Duration | During endoscopy | Total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique. |
| Number of all lesions for each technique | During endoscopy | — |
| Percentage of non-interpretable/assessable endoscopies | During endoscopy | e.g. insufficient preparation, inflammation |
| Location of the lesion | During endoscopy | — |
| Size of the lesion in mm | During endoscopy | — |
| Number of targeted biopsies taken in the different groups. | During endoscopy | — |
Countries
Netherlands
Outcome results
None listed