Texture and Colour Enhancement Imaging (TXI) Versus Dye Chromoendoscopy for Dysplasia Detection in IBD Surveillance.

NCT07208214 | Not Yet Recruiting

• 1 other identifier: RD24/053
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

Brief Summary

In individuals with inflammatory bowel disease (IBD), bowel cancer can develop from abnormal cell changes (dysplasia). Regular colonoscopies are recommended to identify these early changes, which can be difficult to detect because they are often small and subtle. Dye-based imaging has been used to improve detection, but it requires additional preparation and time. Texture and Colour Enhancement Imaging (TXI) is a newer method available in clinical practice that adjusts brightness, colour, and texture on high-definition cameras. This study will compare TXI with dye-based imaging to assess which approach detects precancerous changes more effectively in patients with IBD.

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with dye chromoendoscopy

  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

Dye

OTHER

Participants allocated in the "Dye" group receive withdrawal with Dye chromoendoscopy.

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 "Dye" group receive withdrawal with Dye chromoendoscopy. Both procedures follow standardized protocols outlined in the study design.

Dye; TXI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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
• 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:

• The participant may not enter the study if ANY of the following apply:
• 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).
• Allergy to Indigo Carmine
• Pregnancy
• Unable or unwilling to consent to study participation

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

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: September 17, 2025
• First Posted: October 6, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share