Clinical trial NCT04291976: Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance
Official title: Back-to-back High-definition White Light Endoscopy Versus Single-pass High-definition White Light Endoscopy and Chromoendoscopy in IBD Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Colorectal Neoplasms
Keywords: IBD
Inflammatory Bowel Diseases
Colorectal Cancer
Surveillance
Dysplasia
Back-to-Back
Chromoendoscopy
White light
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Leiden University Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2020-03-02
Enrollment: 563
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter, non-blinded randomized trial with three parallel arms: back-to-back HDWLE, single-pass HDWLE and CE.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: detection rate of neoplasia for each technique
timeFrame: During endoscopy
Secondary outcomes:
measure: Number of all lesions for each technique
timeFrame: During endoscopy
measure: Number of dysplastic lesions for each technique
timeFrame: After each endoscopy, within one month after the procedure.
measure: Kudo classification for each lesion
timeFrame: During endoscopy when a lesion is detected
measure: Duration
timeFrame: During endoscopy
measure: Number of targeted biopsies taken in the different groups.
timeFrame: During endoscopy
measure: Percentage of non-interpretable/assessable endoscopies
timeFrame: During endoscopy
measure: Location of the lesion
timeFrame: During endoscopy
measure: Size of the lesion in mm
timeFrame: During endoscopy
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Utrecht
country: Netherlands
facility: Utrecht University Medical Center
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
state: Noord-Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid Holland
Study officials:
affiliation: Radboud University Medical Center
name: Frank Hoentjen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Bas Oldenburg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: