Impact of Texture and Color Enhancement Imaging on Detection and Miss Rate of Premalignant Lesions: A Multicentre, Randomized, Tandem Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,964
- 主要终点
- sessile serrated lesion detection rate
研究概览
简要总结
Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent
排除标准
- •Surveillance, diagnostic or therapeutic colonoscopy
- •Patients with an already known or suspected colorectal tumour
- •Patients with alarming symptoms and signs, including haematochezia, melena, weight loss or anaemia without specific causes, an abdominal mass and positive digital rectal examination
- •Pregnant or lactating women
- •Patients with gastrointestinal tract obstruction
- •Patients with inflammatory bowel diseases, hereditary CRC syndromes or serrated polyposis syndrome
- •Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- •Patients with failed cecal intubation
- •Patients with poor bowel preparation quality that necessitated a second bowel preparation
- •Patients with a history of colonic resection
研究组 & 干预措施
TXI (Group A)
Arm undergoing colonoscopy with TXI
干预措施: TXI (Group A) (Procedure)
TXI followed by WLI (Group B)
Arm undergoing initial inspection under TXI first, followed by second inspection with WLI
干预措施: TXI followed by WLI (Group B) (Procedure)
WLI (Group C)
Arm undergoing normal colonoscopy with WLI
干预措施: WLI (Group C) (Procedure)
WLI followed by TXI (Group D)
Arm undergoing initial inspection under WLI first, followed by second inspection with TXI
干预措施: WLI followed by TXI (Group D) (Procedure)
结局指标
主要结局
sessile serrated lesion detection rate
时间窗: 1 years
the number of patients with one or more sessile serrated lesions detected and removed divided by the total number of patients
adenoma detection rate
时间窗: 1 years
the number of patients with one or more adenomas detected and removed divided by the total number of patient
次要结局
- sessile serrated lesion miss rate(1 years)
- adenoma miss rate(1 years)