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A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy

A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy for Dysplasia Detection in IBD Surveillance.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07271264
Enrollment
219
Registered
2025-12-09
Start date
2025-12-08
Completion date
2029-03-30
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD

Brief summary

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_TESTTXI

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.

Sponsors

London North West Healthcare NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with high-definition white light endoscopy.6 monthsThe number of dysplastic areas detected during endoscopy

Countries

United Kingdom

Contacts

CONTACTJonathan Landy, Consultant Gastroenterologist
Jonathan.Landy@nhs.net020 8869 544

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026