Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Adenoma Detection Rate
研究概览
简要总结
Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. This technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo, Japan) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and limited to back-to back studies.
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is superior to WL endoscopy in terms of adenoma detection
详细描述
50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT) and meeting all eligibility criteria are randomised 1:1 to LCI (LCI group) or WLI (WL) during insertion and withdrawal phase of colonoscopy. A randomisation list for each participating center was produced by the coordinating center via computer-generated treatment code list. Randomisation is stratified by gender, age (50-60, 61-729 years) and screening history (first vs subsequent test) through an online centralised study database.All procedures are performed with a high-definition ELUXEO 700 series videocolonscopes with or without magnification (EC-760R, EC-760ZP, FUJIFILM Co., Tokyo).
The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT)
排除标准
- •subjects not eligible for invitation in the screening program (colonoscopy already performed in the previous 5 years, personal history of CRC, colonic adenomas or IBD, severe comorbidity, including end-stage cardiovascular, pulmonary, liver or renal disease)
- •patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale > 2 in any colonic segment)
- •patients with previous colonic resection
- •patients on antithrombotic therapy, precluding polyp resection
- •patients who were not able or refused to give informed written consent.
研究组 & 干预措施
LCI
Linked Color Imaging
干预措施: Linked Color Imaging (Device)
WL
White Light
干预措施: Linked Color Imaging (Device)
结局指标
主要结局
Adenoma Detection Rate
时间窗: 1 year
proportion of participants with at least one adenoma (per-patient analysis)
次要结局
- advanced adenoma detection rate(1 year)
- mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions(1 year)
- Withdrawal time(1 year)
研究者
Franco Radaelli
Principal Investigator, Head Endoscopy Unit, Valduce Hospital
Valduce Hospital