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临床试验/NCT03279783
NCT03279783Unknown不适用

LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon

Valduce Hospital2 个研究点 分布在 1 个国家目标入组 752 人开始时间: 2017年7月1日最近更新:
适应症

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

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

发起方
Valduce Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Franco Radaelli

Head of Endoscopy Unit

Valduce Hospital

研究点 (2)

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