Inflammatory Bowel Disease (IBD)NCT07089771
Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy
A study testing Virtual Chromoendoscopy and Dye-Based Chromoendoscopy in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (Disorder), run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis (Disorder), Crohns Disease
- What is being tested?
- Virtual Chromoendoscopy and Dye-Based Chromoendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2026to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of colorectal cancer or prior colectomy
- Contraindications to dye use
- Colonoscopies for therapeutic purposes
- Pregnancy
- Inability to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Karolinska University Hospital
Stockholm, 141 57
Olga Bednarska, MD PhD, 0046703980931, olga.bednarska@regionstockholm.se
About this study
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.
Read more
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.
Read the 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
- Being tested
- Virtual Chromoendoscopy, Dye-Based Chromoendoscopy
- Keywords
- virtual chromoendoscopy, dye-based chromoendoscopy, dysplasia detection, IBD surveillance colonoscopy
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual ChromoendoscopyProcedure or surgery
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 ChromoendoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Dye-Based Chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
The rate of dysplastic lesions detected normalized by the colonoscope withdrawal time (number of dysplasia findings per 10 minutes) during the surveillance colonoscopy.
Measured: Measured during the index colonoscopy procedure.
Positive predictive value (PPV) of targeted biopsies
The proportion of biopsies taken from suspicious lesions that are confirmed histologically as dysplastic or neoplastic.
Measured: Measured during the index colonoscopy and confirmed by pathology.
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.
Measured: Assessed at the time of index colonoscopy and confirmed by pathology.
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.
Measured: Collected within 24-48 hours after the colonoscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Uppsala University Hospital, Sahlgrenska University Hospital, Falu Hospital, Karolinska University Hospital, Örebro University, Sweden, Ersta Diakoni, Saint Göran Hospital, University Hospital, Linkoeping
- Responsible party
- Principal investigator, Olga Bednarska, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089771
- Sponsor's protocol ID
- 2025-02302-01
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 6 Jul 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Versus Dye-based Chromoendoscopy in Inflammatory Bowel Disease Surveillance Colonoscopy
- ClinicalTrials.gov ID
- NCT07089771
- Acronym / sponsor ID
- 2025-02302-01
- Conditions
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis (Disorder), Crohns Disease, Colorectal Neoplasms
- Keywords
- virtual chromoendoscopy, dye-based chromoendoscopy, dysplasia detection, IBD surveillance colonoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Uppsala University Hospital, Sahlgrenska University Hospital, Falu Hospital, Karolinska University Hospital, Örebro University, Sweden, Ersta Diakoni, Saint Göran Hospital, University Hospital, Linkoeping
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Chromoendoscopy (VCE) Group | Experimental | Procedure: Virtual ChromoendoscopyParticipants 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. |
| Dye-Based Chromoendoscopy (DCE) Group | Active comparator | Procedure: Dye-Based ChromoendoscopyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- History of colorectal cancer or prior colectomy
- Contraindications to dye use
- Colonoscopies for therapeutic purposes
- Pregnancy
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual ChromoendoscopyHigh-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. | Procedure or surgery | Virtual Chromoendoscopy (VCE) Group |
| Dye-Based ChromoendoscopyHigh-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. | Procedure or surgery | Dye-Based Chromoendoscopy (DCE) Group |
Primary outcome
Proportion of patients with at least one dysplastic lesion detected during surveillance colonoscopy
Time frame: Measured at the time of the index colonoscopy procedure (baseline) and confirmed by histopathological analysis post-procedure (up to 60 days)
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.
4 secondary outcomes
Number of dysplastic lesions detected per 10 minutes of withdrawal time
Time frame: Measured during the index colonoscopy procedure.
Positive predictive value (PPV) of targeted biopsies
Time frame: Measured during the index colonoscopy and confirmed by pathology.
Type and characterization of detected lesions
Time frame: Assessed at the time of index colonoscopy and confirmed by pathology.
Patient experience and satisfaction
Time frame: Collected within 24-48 hours after the colonoscopy procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Chromoendoscopy and Dye-Based Chromoendoscopy in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis (Disorder), run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga Bednarska, MD PhD (0046703980931, olga.bednarska@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with at least one dysplastic lesion detected during surveillance colonoscopy (time frame: Measured at the time of the index colonoscopy procedure (baseline) and confirmed by histopathological analysis post-procedure (up to 60 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.