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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04291976

Collaborator

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

560

Enrollment

Locations

Arms

23.6

Anticipated Duration (Months)

140

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Colorectal Neoplasms	Procedure: Back-to-back high-definition white light endoscopy Procedure: single-pass high-definition white light endoscopy Procedure: chromoendoscopy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

560 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a multicenter, non-blinded randomized trial with three parallel arms: back-to-back HDWLE, single-pass HDWLE and CE.This is a multicenter, non-blinded randomized trial with three parallel arms: back-to-back HDWLE, single-pass HDWLE and CE.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 13, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: back-to-back HDWLE Similar to single-pass HDWLE, with a second segmental inspection after the first examination in the same session. Equipment is similar to 1.	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.
Active Comparator: single-pass HDWLE 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: 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.
Active Comparator: Chromoendoscopy 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.	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.

Arm

Intervention/Treatment

Experimental: back-to-back HDWLE

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

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.

Active Comparator: single-pass HDWLE

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: single-pass high-definition white light endoscopy

Active Comparator: Chromoendoscopy

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.

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.

Outcome Measures

Primary Outcome Measures

detection rate of neoplasia for each technique [During endoscopy]

Secondary Outcome Measures

Number of all lesions for each technique [During endoscopy]
Number of dysplastic lesions for each technique [After each endoscopy, within one month after the procedure.]
Kudo classification for each lesion [During endoscopy when a lesion is detected]
Duration [During endoscopy]
Total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique.
Number of targeted biopsies taken in the different groups. [During endoscopy]
Percentage of non-interpretable/assessable endoscopies [During endoscopy]
e.g. insufficient preparation, inflammation
Location of the lesion [During endoscopy]
Size of the lesion in mm [During endoscopy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboudumc	Nijmegen	Gelderland	Netherlands	6525GA
2	Utrecht University Medical Center	Utrecht	Gelderland	Netherlands	3584CX
3	Amsterdam UMC, location AMC	Amsterdam	Noord-Holland	Netherlands	1105 AZ
4	Leiden University Medical Center	Leiden	Zuid Holland	Netherlands