NCT03359343

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

November 27, 2017

Last Update Submit

January 11, 2018

Conditions

Colorectal PolypLinked Color ImagingComputer-aided Diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • the short learning curve

    June 1, 2018

  • the correlation

    June 1, 2018

Study Arms (3)

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.

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutive patients undergoing colonoscopy

You may qualify if:

  • \- at least one polyp found during colonoscopy examination.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

RECRUITING

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

Beijing, 100071, China

ACTIVE NOT RECRUITING

Related Publications (3)

  • 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.

    PMID: 26560036BACKGROUND

  • 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.

    PMID: 27641243BACKGROUND

  • 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.

    PMID: 27556101BACKGROUND

Study Officials

  • Yan Liu

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

    STUDY DIRECTOR

Central Study Contacts

Min Min, M.D.

CONTACT

+86-010-66947473minmin823@sina.com

Song Su

CONTACT

+86-010-66947473sssusong0808@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

October 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

CN(2)