跳至主要内容
临床试验/NCT03359343
NCT03359343Unknown不适用

Computer-aided Classification of Colorectal Polyp by Using Linked Colour Imaging

Affiliated Hospital to Academy of Military Medical Sciences2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年10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
250
试验地点
2
主要终点
LCI accuracy

研究概览

简要总结

Linked color imaging (LCI),a new endoscopy modality, creates clear and bright images by using short wavelength narrow band laser light. LCI can make red area appear redder and white areas appear whiter. Thus, it may be possible to distinguish adenoma and non-adenoma polyps based on color evaluation of LCI images. This study aimed to assess the correlation between histology results and LCI images. Moreover, the investigators conducted a pilot study to explore the clinical potential of LCI to distinguish adenoma and non-adenoma polyps and the accuracy of an automatic computer-aided diagnosis system using LCI imagine to predict histology polyps when compared to human experts physicians.

详细描述

This study consists of a retrospective analysis and a pilot study. In the retrospective study, the investigators tried to find out an correlation between LCI images and histology results for polyp lesions. And a computer-aided analysis of the images was conducted to demonstrate the correlation objectively. Thereafter,a pilot study was performed to explore whether the previous correlation could be easily learned to distinguish adenoma and non-adenoma polyps by comparing the results of experts diagnosis of LCI image and non-experts. Also, in the pilot study, the investigators assessed the accuracy of an automate histology diagnosis method for polyp LCI images using the computer-aided system when compared to human experts physicians. Throughout the entire research, histology results are regarded as gold standard.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •at least one polyp found during colonoscopy examination.

排除标准

  • •poor quality of bowel preparation which impedes histology evaluation; previous resection of colon; inflammatory bowel disease; familiar adenomatous polyposis; Peutz-Jeghers syndrome or other polyposis syndrome.

结局指标

主要结局

LCI accuracy

时间窗: June 1, 2018

the accuracy between a novel developed computer-aided diagnosis system and human experts physicians o distinguish adenoma polyps and non-adenoma polyps based on LCI image.

次要结局

  • the correlation(June 1, 2018)
  • the short learning curve(June 1, 2018)

研究者

发起方
Affiliated Hospital to Academy of Military Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (2)

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