An interventional study of Back-to-back high-definition white light endoscopy and single-pass high-definition white light endoscopy in Inflammatory Bowel Diseases and Colorectal Neoplasms, sponsored by Radboud University Medical Center. Completed at 4 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Prevention
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.
5,600 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 563 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
Similar to single-pass HDWLE, with a second segmental inspection after the first examination in the same session. Equipment is similar to 1.
Procedure: Back-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. The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.
Procedure: single-pass high-definition white light endoscopy
After introduction of the endoscope into the colon a dye (methylene blue or 0.3% 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 arms.
Procedure: chromoendoscopy
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.
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
Plan to share: No
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