Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance
NCT04291976 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 563
Last updated 2023-11-21
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.
Conditions
- Inflammatory Bowel Diseases
- Colorectal Neoplasms
Interventions
- 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, 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.
- PROCEDURE
-
single-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.
- PROCEDURE
-
chromoendoscopy
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 & Collaborators
-
UMC Utrecht
collaborator OTHER -
Leiden University Medical Center
collaborator OTHER -
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
collaborator OTHER -
Radboud University Medical Center
lead OTHER
Principal Investigators
-
Frank Hoentjen, MD PhD · Radboud University Medical Center
-
Bas Oldenburg, MD PhD · UMC Utrecht
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-13
- Primary Completion
- 2023-05-23
- Completion
- 2023-11-07
Countries
- Netherlands
Study Locations
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