ClinicalTrials.gg
Not yet recruitingNCT07208214TXIorDyEUpdated Oct 6, 2025

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

An interventional study of TXI in IBD, sponsored by London North West Healthcare NHS Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.

Sponsored by London North West Healthcare NHS Trust · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Bowel cancer in individuals with inflammatory bowel disease (IBD) often develops from abnormal changes in the cells lining the bowel, known as dysplasia. International guidelines recommend undertaking regular colonoscopies to check for precancerous changes in patients with IBD. In the past, these precancerous changes were thought to be invisible, but with improved camera imaging technology, most cases of early changes can now be detected. However, early precancerous changes remain difficult to identify because they often appear as small, flat, and subtle lesions.

Studies have shown that applying dye to the bowel lining during colonoscopy can improve the detection of early changes compared with standard endoscopy. Nevertheless, the use of dye presents challenges, including additional preparation, longer procedure time, and the need for specific training. Newer high-definition cameras have demonstrated higher detection rates than older standard cameras. Advances in imaging technology have also led to the development of novel techniques designed to improve detection and identification of abnormal tissues. One such technique is Texture and Colour Enhancement Imaging (TXI), which enhances texture, brightness, and colour in high-definition cameras, making small and subtle differences in tissue more visible. This technology is now available in routine clinical practice with the EVIS X1 system (Olympus).

No randomized studies have yet evaluated the effectiveness of TXI in detecting early precancerous changes during colonoscopy in patients with IBD. The present study is designed to compare TXI with dye-based imaging in order to determine which method more effectively detects precancerous changes in IBD.

02

Conditions studied

  • IBD
03

In context

Lead sponsor

London North West Healthcare NHS Trust is the lead sponsor of 55 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 ( count \<50) or Coagulopathy precluding
    • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
242 participants (estimated)

Study arms

  • Active comparator
    TXI

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

    Diagnostic Test: TXI

  • Other
    Dye

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

    Diagnostic Test: TXI

Interventions

  • Diagnostic testTXI

    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.

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2025; primary completion for Jul 2027, 21 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2025
First posted
Oct 6, 2025
StartEst.
Oct 1, 2025
Primary completionEst.
Jul 1, 2027
CompletionEst.
Jul 1, 2027
Last update
Oct 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07208214
Lead sponsor
London North West Healthcare NHS Trust
Responsible party
Sponsor
First posted
Oct 6, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Oct 6, 2025

Study contacts

Jonathan Landy, Consultant Gastroenterologist
Contact
Jonathan.Landy@nhs.net
020 8869 544

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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