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Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance

Not Applicable
Completed
Conditions
Inflammatory Bowel Diseases
Colorectal Neoplasms
Registration Number
NCT04291976
Lead Sponsor
Radboud University Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
563
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
detection rate of neoplasia for each techniqueDuring endoscopy
Secondary Outcome Measures
NameTimeMethod
Number of all lesions for each techniqueDuring endoscopy
Number of dysplastic lesions for each techniqueAfter each endoscopy, within one month after the procedure.
Kudo classification for each lesionDuring endoscopy when a lesion is detected
DurationDuring endoscopy

Total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique.

Number of targeted biopsies taken in the different groups.During endoscopy
Percentage of non-interpretable/assessable endoscopiesDuring endoscopy

e.g. insufficient preparation, inflammation

Size of the lesion in mmDuring endoscopy
Location of the lesionDuring endoscopy

Trial Locations

Locations (4)

Radboudumc

🇳🇱

Nijmegen, Gelderland, Netherlands

Utrecht University Medical Center

🇳🇱

Utrecht, Gelderland, Netherlands

Amsterdam UMC, location AMC

🇳🇱

Amsterdam, Noord-Holland, Netherlands

Leiden University Medical Center

🇳🇱

Leiden, Zuid Holland, Netherlands

Radboudumc
🇳🇱Nijmegen, Gelderland, Netherlands

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