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

Radboud University Medical Center

Status: Completed

Conditions: Colorectal Neoplasms; Inflammatory Bowel Diseases

Treatments: Procedure: chromoendoscopy; Procedure: Back-to-back high-definition white light endoscopy; Procedure: single-pass high-definition white light endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04291976

109344

Details and patient eligibility

About

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.

Full 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.

Enrollment: 563 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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563 participants in 3 patient groups

back-to-back HDWLE

Experimental group

Description:

Similar to single-pass HDWLE, with a second segmental inspection after the first examination in the same session. Equipment is similar to 1.

Treatment:

Procedure: Back-to-back high-definition white light endoscopy

single-pass HDWLE

Active Comparator group

Description:

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.

Treatment:

Procedure: single-pass high-definition white light endoscopy

Chromoendoscopy

Active Comparator group

Description:

After introduction of the endoscope into the colon a dye (methylene blue or 0.3% 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 arms.

Treatment:

Procedure: chromoendoscopy