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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03359343
Other study ID # 307-LCI-CAD
Secondary ID
Status Recruiting
Phase N/A
First received November 27, 2017
Last updated January 11, 2018
Start date October 1, 2017
Est. completion date February 1, 2018

Study information

Verified date January 2018
Source Affiliated Hospital to Academy of Military Medical Sciences
Contact Min Min, M.D.
Phone +86-010-66947473
Email minmin823@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date February 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 80 Years
Eligibility 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


Locations

Country Name City State
China Affiliated Hospital to Academy of Military Medical Sciences Beijing Beijing
China Department of Gastroenterology, Affilited Hospital to Academy of Military Medical Sciences Beijing

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary the correlation the correlation between LCI image and histology results were retrospectively explored June 1, 2018
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