Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy
Not applicable · Testing Virtual Chromoendoscopy and Dye-Based Chromoendoscopy · 1 site · Region Stockholm
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Virtual Chromoendoscopy (a procedure) and Dye-Based Chromoendoscopy (a procedure) as a way to diagnose or measure disease. Condition(s) listed: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (Disorder) and Crohns Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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)
Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 480 participants are expected to take part.
- Start date: 2026-05-01 (planned).
- Main results expected around 2029-12-31 (estimate from the record).
- 1 study site listed in Sweden.
Main thing being measured
- Proportion of patients with at least one dysplastic lesion detected during surveillance colonoscopy (Measured at the time of the index colonoscopy procedure (baseline) and confirmed by histopathological analysis…)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Ulcerative Colitis (Disorder); Crohns Disease; Colorectal Neoplasms |
| Lead sponsor | Region Stockholm |
| Collaborators | Uppsala University Hospital; Sahlgrenska University Hospital; Falu Hospital; Karolinska University Hospital; Örebro University, Sweden; Ersta Diakoni; Saint Göran Hospital; University Hospital, Linkoeping |
| Enrollment | 480 (estimated) |
| Start date | 2026-05-01 |
| Primary completion (est.) | 2029-12-31 |
| First posted | 2025-07-28 |
| Last updated | 2026-03-20 |
| Official title | Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy |
| ClinicalTrials.gov ID | NCT07089771 |
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 eliminat… - 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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.