LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 752
- 试验地点
- 2
- 主要终点
- Right colon adenoma miss rate
研究概览
简要总结
Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a significant adenoma miss rate still exists, particularly in the right colon. Optimizing the detection of adenomas and sessile serrated lesions in the right colon is crucial to increase the effectiveness of colonoscopy in colorectal cancer prevention.
Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently developed technology that differentiates the red colour spectrum more effectively than White Light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. The increased colour contrast results in more accurate delineation of abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that LCI may be improve the detection of neoplastic lesion of colon.
The investigators performe a tandem prospective study to compare the right colon adenoma miss rates of LCI colonoscopy with those of conventional white light colonoscopy.
Therefore participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first. The endoscopist are masked to group allocation until immediately before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700 (EC-760R, EC-760ZP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all outpatients referred for colonoscopy
排除标准
- •inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) < 2 in one colonic segment)
- •previous colonic resection
- •inflammatory bowel disease
- •ereditary polyposic syndromes
- •patients on antithrombotics precluding polyp recetion
- •absence of informed consent
- •inpatients or patients undergoing urgent colonscopy
结局指标
主要结局
Right colon adenoma miss rate
时间窗: One year
Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection
次要结局
- Right colon sessile serrated lesions miss rate(One year)
- Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate(One year)
研究者
Franco Radaelli
Head of Endoscopy Unit
Valduce Hospital
