Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy

NCT07089771 | Not Yet Recruiting

• 1 other identifier: 2025-02302-01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

People with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease affecting the colon, have a higher risk of developing colon cancer over time. To catch early signs of cancer, regular colonoscopies are recommended. In this study, the investigators are comparing two advanced methods of examining the colon during these surveillance colonoscopies. One method uses a special dye sprayed inside the colon to highlight abnormal areas (called dye-based chromoendoscopy). The other method uses new technology built into the camera to enhance the view without needing any dye (called virtual chromoendoscopy). Both methods use modern, high-definition equipment. The purpose of this study is to find out if the newer, dye-free method is as good as the traditional dye method at detecting pre-cancerous changes (called dysplasia) in people with IBD. Adults with IBD who are due for a routine surveillance colonoscopy may be invited to take part. Participants will be randomly assigned to one of the two methods. No additional procedures are involved, and only the way the colon is viewed differs. The investigators will also look at how long the procedures take, how many biopsies are needed, any complications, and how patients experience the exam. Participants will be followed over time using national health records to check for long-term outcomes. This research will help doctors better understand which method is most effective and comfortable for patients, and may guide future recommendations for cancer screening in people with IBD.

Conditions

Inflammatory Bowel Disease (IBD); Ulcerative Colitis (Disorder); Crohns Disease; Colorectal Neoplasms

Keywords

virtual chromoendoscopy; dye-based chromoendoscopy; dysplasia detection; IBD surveillance colonoscopy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with at least one dysplastic lesion detected during surveillance colonoscopy

  The primary endpoint is the proportion of enrolled patients in each study arm (HD-VCE and HD-DCE) who have at least one histologically confirmed dysplastic lesion (including low-grade dysplasia, high-grade dysplasia, or colorectal cancer) detected during the index surveillance colonoscopy.

  Measured at the time of the index colonoscopy procedure (baseline) and confirmed by histopathological analysis post-procedure (up to 60 days)

Secondary Outcomes (4)

• Number of dysplastic lesions detected per 10 minutes of withdrawal time

  Measured during the index colonoscopy procedure.

• Positive predictive value (PPV) of targeted biopsies

  Measured during the index colonoscopy and confirmed by pathology.

• Type and characterization of detected lesions

  Assessed at the time of index colonoscopy and confirmed by pathology.

• Patient experience and satisfaction

  Collected within 24-48 hours after the colonoscopy procedure.

Study Arms (2)

Virtual Chromoendoscopy (VCE) Group

EXPERIMENTAL

Participants randomized to this arm will undergo surveillance colonoscopy using high-definition virtual chromoendoscopy. This technique enhances mucosal visualization through advanced imaging technology without the use of dyes. The colonoscope's built-in virtual chromoendoscopy mode will be used to detect and characterize dysplastic lesions during withdrawal.

Procedure: Virtual Chromoendoscopy

Dye-Based Chromoendoscopy (DCE) Group

ACTIVE COMPARATOR

Participants randomized to this arm will undergo surveillance colonoscopy using high-definition dye-based chromoendoscopy. Indigo carmine dye will be sprayed segmentally on the colonic mucosa via a dye spray catheter to enhance visualization of mucosal patterns and detect dysplasia. Targeted biopsies will be taken from suspicious areas identified with dye staining.

Procedure: Dye-Based Chromoendoscopy

Interventions

Virtual Chromoendoscopy PROCEDURE

High-Definition Virtual Chromoendoscopy (HD-VCE): Surveillance colonoscopy using high-definition virtual chromoendoscopy enhances mucosal visualization through advanced imaging filters integrated into the colonoscope. This dye-free technique improves detection of dysplasia by increasing contrast and highlighting subtle mucosal patterns during withdrawal. HD-VCE reduces procedure time and eliminates risks related to dye application, offering a practical alternative to dye-based methods. Its efficacy in IBD surveillance requires further validation.

Virtual Chromoendoscopy (VCE) Group

Dye-Based Chromoendoscopy PROCEDURE

High-Definition Dye-Based Chromoendoscopy (HD-DCE): Surveillance colonoscopy using high-definition dye-based chromoendoscopy involves segmental application of indigo carmine dye via a spray catheter. The dye enhances mucosal surface patterns, aiding dysplasia detection. HD-DCE is currently considered a gold standard in IBD surveillance due to superior dysplasia detection rates.

Dye-Based Chromoendoscopy (DCE) Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years and one of the criteria beneath:
• Extensive ulcerative colitis or indeterminate colitis (IBD-U), or Crohn's colitis involving at least one-third of the colon, with a disease history of at least 8 years
• IBD or IBD-U with primary sclerosing cholangitis (PSC)
• IBD or IBD-U with a family history of colorectal cancer in a first-degree relative

You may not qualify if:

• History of colorectal cancer or prior colectomy
• Contraindications to dye use
• Colonoscopies for therapeutic purposes
• Pregnancy
• Inability to consent

Sponsors & Collaborators

• Örebro University, Sweden: collaborator
• Saint Göran Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• Uppsala University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Falu Hospital: collaborator
• Karolinska University Hospital: collaborator
• Ersta Diakoni: collaborator
• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 141 57, Sweden

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Olga Bednarska, MD PhD

CONTACT

0046703980931; olga.bednarska@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study uses a parallel assignment model, where participants with inflammatory bowel disease undergoing surveillance colonoscopy are randomly assigned to one of two groups: high-definition virtual chromoendoscopy (HD-VCE) or high-definition dye-based chromoendoscopy (HD-DCE). Each participant receives only one of the two interventions, and outcomes are compared between these independent groups. Randomization is performed prior to the procedure. The parallel design allows direct comparison of dysplasia detection rates between the two techniques without carryover effects, making it appropriate for evaluating the non-inferiority of HD-VCE compared to the current standard HD-DCE.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 28, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)