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

NCT ID: NCT07089771

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2032-12-31

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.

Detailed Description

This is a multicenter, prospective, randomized, non-inferiority clinical trial designed to compare the diagnostic performance of two high-definition endoscopic imaging techniques used during surveillance colonoscopy in patients with longstanding inflammatory bowel disease (IBD) who are at increased risk for colorectal cancer. Participants will be randomly assigned to undergo colonoscopy using either a virtual (dye-free) chromoendoscopy method or a conventional dye-based chromoendoscopy technique. The primary objective is to evaluate whether virtual chromoendoscopy is non-inferior to dye- based chromoendoscopy in detecting dysplasia, a precancerous condition in the colon. Secondary outcomes include the number and type of lesions detected, predictive accuracy of targeted biopsies, examination times, patient-reported experience, complication rates, and biopsy frequency. Eligible participants are adults with a history of extensive colonic IBD of at least eight years, or additional high-risk factors such as primary sclerosing cholangitis or family history of colorectal cancer. Patients with previous colorectal cancer, prior colectomy, known untreated dysplasia, or contraindications to dye application will be excluded. All procedures will be performed using high-definition equipment and standardized bowel preparation protocols. The study includes long-term follow-up through national health registries to evaluate cancer outcomes and subsequent procedures at one and three years post-colonoscopy. The trial will be conducted across several academic and regional centers in Sweden, with an anticipated enrollment of approximately 480 patients to account for potential attrition. This study seeks to inform future guidelines by determining whether a less resource-intensive and potentially more patient-friendly method can provide equivalent surveillance efficacy in this high-risk population.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Virtual Chromoendoscopy (VCE) Group

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.

Group Type: EXPERIMENTAL

Virtual Chromoendoscopy

Intervention Type: 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.

Dye-Based Chromoendoscopy (DCE) Group

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.

Group Type: ACTIVE_COMPARATOR

Dye-Based Chromoendoscopy

Intervention Type: 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.

Interventions

Virtual Chromoendoscopy

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.

Intervention Type: PROCEDURE

Dye-Based Chromoendoscopy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Falu Hospital

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: collaborator

Ersta Diakoni

OTHER

Sponsor Role: collaborator

Saint Göran Hospital

UNKNOWN

Sponsor Role: collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Olga Bednarska

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Linkoping

Linköping, Östergötland County, Sweden

Countries

Sweden

Central Contacts

Olga Bednarska, MD PhD

Role: CONTACT

olga.bednarska@regionostergotland.se

0046703980931

Facility Contacts

Olga Bednarska, MD PhD

Role: primary

olga.bednarska@regionostergotland.se

0046703980931

Other Identifiers

2025-02302-01

Identifier Type: -

Identifier Source: org_study_id