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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291976 on ClinicalTrials.gov