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

Official title

A Randomised Parallel-group Study of Texture and Colour Enhancement Imaging (TXI) Versus Dye Chromoendoscopy for Dysplasia Detection in IBD Surveillance.

Overview

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.

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.

Interventions

• Diagnostic test TXI
  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.

Primary outcome measures

• To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with dye chromoendoscopy [Time frame: 6 months]

Eligibility criteria

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

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07208214 · RD24/053

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗