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.
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
History of colorectal cancer or prior colectomy
Contraindications to dye use
Colonoscopies for therapeutic purposes
Pregnancy
Parallel
Virtual Chromoendoscopy
Procedure/SurgeryHigh-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
Procedure/SurgeryHigh-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.
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.
Number of dysplastic lesions detected per 10 minutes of withdrawal time
The rate of dysplastic lesions detected normalized by the colonoscope withdrawal time (number of dysplasia findings per 10 minutes) during the surveillance colonoscopy.
Positive predictive value (PPV) of targeted biopsies
The proportion of biopsies taken from suspicious lesions that are confirmed histologically as dysplastic or neoplastic.
Type and characterization of detected lesions
Classification and histopathological characterization of lesions detected, including cancer, adenomas with low- or high-grade dysplasia, sessile serrated lesions (with or without dysplasia), hyperplastic polyps, inflammatory or post-inflammatory polyps, and non-dysplastic lesions.
Patient experience and satisfaction
Self-reported patient experience and satisfaction scores collected using the validated survey Patient Experience Colonoscopy Scale (PECS), evaluating comfort and acceptability of each colonoscopy method. Survey responses are rated on a 4-point Likert scale ranging from very poor agreement to very good agreement, with higher values representing better outcomes.
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Region Stockholm
Lead sponsor
Karolinska University Hospital
Sponsor institution
Uppsala University Hospital
Collaborator
Sahlgrenska University Hospital
Collaborator
Falu Hospital
Collaborator
Karolinska University Hospital
Collaborator
Örebro University, Sweden
Collaborator
Ersta Diakoni
Collaborator
Saint Göran Hospital
Collaborator
University Hospital, Linkoeping
Collaborator
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