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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

History of colorectal cancer or prior colectomy

Contraindications to dye use

Colonoscopies for therapeutic purposes

Pregnancy

Trial design

Treatments tested in this trial

  • Virtual Chromoendoscopy
  • Dye-Based Chromoendoscopy

Treatment groups

480 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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