ColitisIST-DDCNCT06223347
Improved and Simplified Staining Technique for Dysplasia Detection in Colitis
An observational study of Colitis and Colonic Dysplasia, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Comparing chromoendoscopy to a digital staining technique and White light in patients with IBD attending scheduled surveillance colonoscopy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Colonic Dysplasia, Inflammatory Bowel Diseases
- What is being tested?
- Chromoendoscopy
- How many people
- 106 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2024to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Our study is directed to the IBD patients who have to undergo a surveillance colonscopy to early detection of dysplasia.
Who may be able to join
- Person schedules to IBD- surveillance colonoscopy.
Who cannot join
- Total Colectomy.
- Not well prepared Bowel. BBPS under 2 at any segement.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Molndal, 43180
Naz Mohammed Salih, Dr., +46720267227, naz.mohammed.salih@vgregion.se
About this study
Official title: A Prospective Trial Comparing Chromoendoscopy to a Digital Staining Technique and White Light in High Definition Colonoscopy in Patients With IBD Attending Scheduled Surveillance Colonoscopy
Comparing chromoendoscopy to a digital staining technique and White light in patients with IBD attending scheduled surveillance colonoscopy
Read the detailed description
In this study we will attempt to compare dye based chromoendoscopy to WLI (white light), NBI( Narrow Band Imaging) and TXI( Texture and Colour Enhancement Imaging). High Definition Colonoscopy is used. We aim to compare all these dye/lights to each other and find the best and simplest method to help to diagnose dysplasia more efficient and easier.
- Being tested
- Chromoendoscopy
- Medical subject headings
- Colitis, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromoendoscopyDiagnostic test
Also called NBI(Narrow Band Imaging), WLI(White light), TXI( Texture and Colour Enhancement Imaging)
Chromoendoscopy: is a dye based staining of colonic mucosa. NBI: is an optical image enhancing technology that allows a detailed inspection of vascular and mucosal patterns, providing the ability to predict histology during real-time endoscopy.
TXI: is a digital technique that enhance texture and color of the tissues to be more visible.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysplasia detection rate
Dysplasia detection rate for each staining technique
Measured: 90 minutes
Secondary outcomes (4)
Hyperplasia detection rate
Hyperplasia detection rate for each staining technique
Measured: 90 minutes
Adenoma detection rate, ADR
Adenoma detection rate, ADR, for each staining technique
Measured: 90 minutes
Bowel cleansing quality according to Bowel Boston Preparation Scale
Measured: 90 minutes
Serious adverse events (significant bleedings and perforations)
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223347
- Sponsor's protocol ID
- 281337
- Acronym
- IST-DDC
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Comparing Chromoendoscopy to a Digital Staining Technique and White Light in High Definition Colonoscopy in Patients With IBD Attending Scheduled Surveillance Colonoscopy
- ClinicalTrials.gov ID
- NCT06223347
- Acronym / sponsor ID
- IST-DDC / 281337
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Jan 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 25 Jan 2024 (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.
Comparing chromoendoscopy to a digital staining technique and White light in patients with IBD attending scheduled surveillance colonoscopy
Detailed description
In this study we will attempt to compare dye based chromoendoscopy to WLI (white light), NBI( Narrow Band Imaging) and TXI( Texture and Colour Enhancement Imaging). High Definition Colonoscopy is used. We aim to compare all these dye/lights to each other and find the best and simplest method to help to diagnose dysplasia more efficient and easier.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study is directed to the IBD patients who have to undergo a surveillance colonscopy to early detection of dysplasia.
Key inclusion criteria (1 listed)
- Person schedules to IBD- surveillance colonoscopy.
Key exclusion criteria (3 listed)
- Total Colectomy.
- Not well prepared Bowel. BBPS under 2 at any segement.
- Pregnancy.
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 |
|---|---|---|
| ChromoendoscopyAlso: NBI(Narrow Band Imaging), WLI(White light), TXI( Texture and Colour Enhancement Imaging)Chromoendoscopy: is a dye based staining of colonic mucosa. NBI: is an optical image enhancing technology that allows a detailed inspection of vascular and mucosal patterns, providing the ability to predict histology during real-time endoscopy. TXI: is a digital technique that enhance texture and color of the tissues to be more visible. | Diagnostic test | – |
Primary outcome
Dysplasia detection rate
Time frame: 90 minutes
Dysplasia detection rate for each staining technique
4 secondary outcomes
Hyperplasia detection rate
Time frame: 90 minutes
Adenoma detection rate, ADR
Time frame: 90 minutes
Bowel cleansing quality according to Bowel Boston Preparation Scale
Time frame: 90 minutes
Serious adverse events (significant bleedings and perforations)
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis and Colonic Dysplasia, run by Vastra Gotaland Region 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naz Mohammed Salih, Dr. (+46720267227, naz.mohammed.salih@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysplasia detection rate (time frame: 90 minutes). 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 25 Jan 2024.