Computer-assisted Diagnosis System Based on Linked Colour Imaging

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100071
    • Active, not recruiting
    • Department of Gastroenterology, Affilited Hospital to Academy of Military Medical Sciences
  • Beijing
    • Beijing, Beijing, China, 100071
      • Recruiting
      • Affiliated Hospital to Academy of Military Medical Sciences
      • Contact: Yan Liu, Ph.D.; Phone Number: 010-66947473; Email: 13911798288@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

consecutive patients undergoing colonoscopy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
experts; In this group, two experts distinguish a set of polyps on LCI images as adenoma or non-adenoma.
non-experts; In this group, two non-experts distinguish the set of polyps(the same to experts group) on LCI images as adenoma or non-adenoma.
Computer-aided diagnosis system; In this group, a newly developed computer-aided diagnosis system will be used to distinguish a set of polyps as adenoma or non-adenoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LCI accuracy	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.	June 1, 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the short learning curve	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.	June 1, 2018
the correlation	the correlation between LCI image and histology results were retrospectively explored	June 1, 2018

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Study Director: Yan Liu, Department of gastroenterology, Affiliated Hospital to Academy of Military Medical Sciences.

Publications and helpful links

General Publications

• Sun X, Dong T, Bi Y, Min M, Shen W, Xu Y, Liu Y. Linked color imaging application for improving the endoscopic diagnosis accuracy: a pilot study. Sci Rep. 2016 Sep 19;6:33473. doi: 10.1038/srep33473.
• Dohi O, Yagi N, Onozawa Y, Kimura-Tsuchiya R, Majima A, Kitaichi T, Horii Y, Suzuki K, Tomie A, Okayama T, Yoshida N, Kamada K, Katada K, Uchiyama K, Ishikawa T, Takagi T, Handa O, Konishi H, Naito Y, Itoh Y. Linked color imaging improves endoscopic diagnosis of active Helicobacter pylori infection. Endosc Int Open. 2016 Jul;4(7):E800-5. doi: 10.1055/s-0042-109049.
• Fukuda H, Miura Y, Hayashi Y, Takezawa T, Ino Y, Okada M, Osawa H, Lefor AK, Yamamoto H. Linked color imaging technology facilitates early detection of flat gastric cancers. Clin J Gastroenterol. 2015 Dec;8(6):385-9. doi: 10.1007/s12328-015-0612-9. Epub 2015 Nov 11.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Disease; Polyps
• Other Study ID Numbers: 307-LCI-CAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No