A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TXI.
- Who it may be relevant to
- Registry conditions: IBD. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy for Dysplasia Detection in IBD Surveillance.
Overview
Texture and Colour Enhancement Imaging (TXI) improves texture, brightness, and colour in white-light endoscopy to highlight subtle tissue differences. Now available through the EVIS X1 system, early evidence suggests potential value in IBD. Studies show that TXI may help predict ulcerative colitis relapse and performs comparably to dye chromoendoscopy in detecting lesions, though no randomised data exist for dysplasia detection in IBD surveillance. We therefore propose a randomised paired study comparing TXI with high-definition white-light endoscopy for dysplasia detection in IBD surveillance.
Detailed description
Texture and colour enhancement imaging (TXI) is designed to enhance texture, brightness and colour in white light in order to clearly define subtle tissue differences. This has been shown to enhance subtle tissue differences (20). This technology has recently become available in routine clinical practice with introduction of the EVIS X1 system (Olympus). Some promising data about the use of TXI in IBD are emerging. In a prospective observational study, 146 UC patients in endoscopic remission were evaluated with WLE and TXI. Patients with accentuated redness and poor visibility of deep vessels at TXI had significantly lower UC relapse-free rates than patients with no redness or accentuated redness alone, suggesting a possible role of TXI in guiding treatment intensification (21). In a small study of 16 IBD patients undergoing surveillance colonoscopy, TXI missed no lesions detected by subsequent dye chromoendoscopy (22). There are no randomised data regarding the utility of TXI for detection of dysplasia in colonoscopy IBD surveillance. We propose to undertake a randomised paired design study of Texture and Colour Enhancement Imaging (TXI) versus high-definition white light endoscopy for dysplasia detection in IBD surveillance.
Interventions
- Diagnostic test TXI
Participants allocated to the "TXI" group undergo withdrawal using Texture and Colour Enhancement Imaging, while those in the "white light" group receive withdrawal with with high-definition white light endoscopy. Both procedures follow standardized protocols outlined in the study design.
Primary outcome measures
- To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with high-definition white light endoscopy. [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patients >16 with inflammatory bowel disease undergoing surveillance colonoscopy.
- Patients with Crohn's (L2/L3 Montreal classification) with >50% colonic involvement OR
- Patients with ulcerative colitis with Extensive or left sided disease (E3 or E2 Montreal classification) for at least 8 years or a diagnosis of Primary sclerosing cholangitis concomitant with IBD.
Exclusion criteria
- Disease duration <8 years unless a diagnosis of PSC
- Incomplete colonoscopy
- BBPS <6 or <2 in any segment
- MES ≥2 or any variable of the SES-CD is ≥2 or any stenosis for >10cm segment (above the rectum)
- Previous colorectal resection
- Thrombocytopaenia (platelet count <50) or Coagulopathy precluding biopsy
- Anticoagulation that has not been held appropriately prior to the procedure (must be held at least the morning of the procedure).
- Pregnancy
- Unable or unwilling to consent to study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United Kingdom · 1 center
- Central Middlesex Hospital — London
Identifiers
NCT: NCT07271264 · RD25/051