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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
563
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.
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.
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.
Radboudumc
Nijmegen, Gelderland, Netherlands
Utrecht University Medical Center
Utrecht, Gelderland, Netherlands
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
detection rate of neoplasia for each technique
Time frame: During endoscopy
Number of all lesions for each technique
Time frame: During endoscopy
Number of dysplastic lesions for each technique
Time frame: After each endoscopy, within one month after the procedure.
Kudo classification for each lesion
Time frame: During endoscopy when a lesion is detected
Duration
Total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique.
Time frame: During endoscopy
Number of targeted biopsies taken in the different groups.
Time frame: During endoscopy
Percentage of non-interpretable/assessable endoscopies
e.g. insufficient preparation, inflammation
Time frame: During endoscopy
Location of the lesion
Time frame: During endoscopy
Size of the lesion in mm
Time frame: During endoscopy
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