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

ConditionIBD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorLondon North West Healthcare NHS Trust

About this trial

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.

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 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.

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 "white light" group receive withdrawal with with high-definition white light endoscopy. Both procedures follow standardized protocols outlined in the study design.

Treatment groups

219 Participants
are divided into 2 treatment groups
Group A: TXIActive comparator 1 intervention
Group B: White lightOther 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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