A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy for Dysplasia Detection in IBD Surveillance.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with high-definition white light endoscopy.
研究概览
简要总结
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.
详细描述
Texture and colour enhancement imaging (TXI) is designed to enhance texture, brightness and colour in white light in order to clearly define subtle tissue differences. This has been shown to enhance subtle tissue differences (20). This technology has recently become available in routine clinical practice with introduction of the EVIS X1 system (Olympus). Some promising data about the use of TXI in IBD are emerging. In a prospective observational study, 146 UC patients in endoscopic remission were evaluated with WLE and TXI. Patients with accentuated redness and poor visibility of deep vessels at TXI had significantly lower UC relapse-free rates than patients with no redness or accentuated redness alone, suggesting a possible role of TXI in guiding treatment intensification (21). In a small study of 16 IBD patients undergoing surveillance colonoscopy, TXI missed no lesions detected by subsequent dye chromoendoscopy (22). There are no randomised data regarding the utility of TXI for detection of dysplasia in colonoscopy IBD surveillance. We propose to undertake a randomised paired design study of Texture and Colour Enhancement Imaging (TXI) versus high-definition white light endoscopy for dysplasia detection in IBD surveillance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •Pregnancy
- •Unable or unwilling to consent to study participation
研究组 & 干预措施
TXI
Participants allocated to the "TXI" group undergo withdrawal using Texture and Colour Enhancement Imaging
干预措施: TXI (Diagnostic Test)
White light
Participants allocated in the "White light " group receive withdrawal with White light
干预措施: TXI (Diagnostic Test)
结局指标
主要结局
To compare the proportion of patients with at least 1 dysplastic lesion detected using TXI compared with high-definition white light endoscopy.
时间窗: 6 months
The number of dysplastic areas detected during endoscopy
次要结局
未报告次要终点