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Completed

NCT Number: NCT04291976

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Back-to-back high-definition white light endoscopy

Procedure

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.

single-pass high-definition white light endoscopy

Procedure

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.

chromoendoscopy

Procedure

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.

Primary outcomes

  1. detection rate of neoplasia for each technique

    Time frame: During endoscopy

Secondary outcomes

  1. Number of all lesions for each technique

    Time frame: During endoscopy

  2. Number of dysplastic lesions for each technique

    Time frame: After each endoscopy, within one month after the procedure.

  3. Kudo classification for each lesion

    Time frame: During endoscopy when a lesion is detected

  4. Duration

    Time frame: During endoscopy

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

  5. Number of targeted biopsies taken in the different groups.

    Time frame: During endoscopy

  6. Percentage of non-interpretable/assessable endoscopies

    Time frame: During endoscopy

    e.g. insufficient preparation, inflammation

  7. Location of the lesion

    Time frame: During endoscopy

  8. Size of the lesion in mm

    Time frame: During endoscopy

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Leiden University Medical Center
  • UMC Utrecht

Registry information

Official study title

Back-to-back High-definition White Light Endoscopy Versus Single-pass High-definition White Light Endoscopy and Chromoendoscopy in IBD Surveillance

Acronym: HELIOS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2020
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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