Computer-assisted Diagnosis System Based on Linked Colour Imaging

NCT ID: NCT03359343

Last Updated: 2018-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-02-01

Brief Summary

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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

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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.

Conditions

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Colorectal Polyp Linked Color Imaging Computer-aided Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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experts

In this group, two experts distinguish a set of polyps on LCI images as adenoma or non-adenoma.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Liu

Role: STUDY_DIRECTOR

Department of gastroenterology, Affiliated Hospital to Academy of Military Medical Sciences.

Locations

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Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Department of Gastroenterology, Affilited Hospital to Academy of Military Medical Sciences

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Countries

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China

Central Contacts

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Min Min, M.D.

Role: CONTACT

+86-010-66947473

Song Su

Role: CONTACT

+86-010-66947473

Facility Contacts

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Yan Liu, Ph.D.

Role: primary

010-66947473

References

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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.

Reference Type BACKGROUND
PMID: 26560036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27641243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27556101 (View on PubMed)

Other Identifiers

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307-LCI-CAD

Identifier Type: -

Identifier Source: org_study_id

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