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

Inflammatory Bowel Diseases Clinical Trial

— HELIOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291976
• Other study ID #: 109344
• Status: Completed
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: November 7, 2023

Study information

• Verified date: November 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: November 7, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam	Noord-Holland
Netherlands	Leiden University Medical Center	Leiden	Zuid Holland
Netherlands	Radboudumc	Nijmegen	Gelderland
Netherlands	Utrecht University Medical Center	Utrecht	Gelderland

Sponsors (4)

Lead Sponsor	Collaborator
Radboud University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Leiden University Medical Center, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection rate of neoplasia for each technique		During endoscopy
Secondary	Number of all lesions for each technique		During endoscopy
Secondary	Number of dysplastic lesions for each technique		After each endoscopy, within one month after the procedure.
Secondary	Kudo classification for each lesion		During endoscopy when a lesion is detected
Secondary	Duration	Total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique.	During endoscopy
Secondary	Number of targeted biopsies taken in the different groups.		During endoscopy
Secondary	Percentage of non-interpretable/assessable endoscopies	e.g. insufficient preparation, inflammation	During endoscopy
Secondary	Location of the lesion		During endoscopy
Secondary	Size of the lesion in mm		During endoscopy