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

NCT07271264 | Recruiting

• 1 other identifier: RD25/051
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with high-definition white light endoscopy.

  The number of dysplastic areas detected during endoscopy

  6 months

Study Arms (2)

TXI

ACTIVE COMPARATOR

Participants allocated to the "TXI" group undergo withdrawal using Texture and Colour Enhancement Imaging

Diagnostic Test: TXI

White light

OTHER

Participants allocated in the "White light " group receive withdrawal with White light

Diagnostic Test: TXI

Interventions

TXI DIAGNOSTIC_TEST

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.

TXI; White light

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

Central Middlesex Hospital

London, NW10 7NS, United Kingdom

RECRUITING

Central Study Contacts

Jonathan Landy, Consultant Gastroenterologist

CONTACT

020 8869 544; Jonathan.Landy@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 8, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)