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

NCT04291976 | Completed DMC

• 1 other identifier: 109344
• Study Type: interventional
• Target: 563
• Locations: 1 country
• Sites: 4

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.

Conditions

Inflammatory Bowel Diseases; Colorectal Neoplasms

Keywords

IBD; Inflammatory Bowel Diseases; Colorectal Cancer; Surveillance; Dysplasia; Back-to-Back; Chromoendoscopy; White light

Outcome Measures

Primary Outcomes (1)

• detection rate of neoplasia for each technique

  During endoscopy

Secondary Outcomes (8)

• 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

• Number of targeted biopsies taken in the different groups.

  During endoscopy

Study Arms (3)

back-to-back HDWLE

EXPERIMENTAL

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

single-pass HDWLE

ACTIVE COMPARATOR

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

Chromoendoscopy

ACTIVE COMPARATOR

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

Interventions

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.

back-to-back HDWLE

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.

single-pass HDWLE

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.

Chromoendoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Utrecht University Medical Center

Utrecht, Gelderland, 3584CX, Netherlands

Location

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Leiden University Medical Center

Leiden, South Holland, Netherlands

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Rectal Diseases

Study Officials

• Frank Hoentjen, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Bas Oldenburg, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start: March 13, 2020
• Primary Completion: May 23, 2023
• Study Completion: November 7, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4)