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

ConditionIBD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon North West Healthcare NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

242 Participants
are divided into 2 treatment groups
Group A: TXIActive comparator 1 intervention
Group B: DyeOther 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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