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

Back-to-back High-definition White Light Endoscopy Versus Single-pass High-definition White Light 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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Inflammatory Bowel Diseases
• Intervention / Treatment: Procedure: Back-to-back high-definition white light endoscopy; Procedure: single-pass high-definition white light endoscopy; Procedure: chromoendoscopy

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 Type: Interventional
• Enrollment (Actual): 563
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboudumc
    • Utrecht, Gelderland, Netherlands, 3584CX
      • Utrecht University Medical Center
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Amsterdam UMC, location AMC
  • Zuid Holland
    • Leiden, Zuid Holland, Netherlands
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
detection rate of neoplasia for each technique	During endoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Total endoscopic procedure time and endoscopic procedure time during withdrawal for each technique.	During endoscopy
Number of targeted biopsies taken in the different groups.		During endoscopy
Percentage of non-interpretable/assessable endoscopies	e.g. insufficient preparation, inflammation	During endoscopy
Location of the lesion		During endoscopy
Size of the lesion in mm		During endoscopy

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: UMC Utrecht; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Leiden University Medical Center
• Investigators: Principal Investigator: Frank Hoentjen, MD PhD, Radboud University Medical Center; Principal Investigator: Bas Oldenburg, MD PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): November 7, 2023

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal Cancer; IBD; Inflammatory Bowel Diseases; Surveillance; Chromoendoscopy; Dysplasia; Back-to-Back; White light
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 109344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No