Computer-assisted Diagnosis System Based on Linked Colour Imaging

• Conditions: Linked Color Imaging; Computer-aided Diagnosis; Colorectal Polyp

• Registration Number: NCT03359343
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-12
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• at least one polyp found during colonoscopy examination.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LCI accuracy	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.

Secondary Outcome Measures

Name	Time	Method
the short learning curve	June 1, 2018	the accuracy between experts and non-experts to distinguish adenoma polyps and non-adenoma polyps based on LCI image was compared to explore whether LCI method is of an shorter learning curve.
the correlation	June 1, 2018	the correlation between LCI image and histology results were retrospectively explored

Trial Locations

Locations (2)

Affiliated Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, Beijing, China

Department of Gastroenterology, Affilited Hospital to Academy of Military Medical Sciences; 🇨🇳 Beijing, China