Application of Artificial Intelligence for Early Diagnosis of Gastric Cancer During Optical Enhancement Magnifying Endoscopy

Sponsor
Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04563416
Collaborator
(none)
80
1
5.7
14.1

Study Details

Study Description

Brief Summary

Previous prospective randomized controlled study demonstrated higher accuracy rate of diagnosing early gastric cancers by Magnifying image-enhanced endoscopy than conventional white-light endoscopy. Nevertheless, it is difficult to differentiate early gastric cancer from noncancerous lesions for beginner. we developed a new computer-aided system to assist endoscopists in identifying early gastric cancers in magnifying optical enhancement images.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Gastric cancer is the third most common cause of cancer-associated deaths worldwide especially in Asia.Early detection and treatment would cure the disease with 5-year survival rate greater than 90%.However, the sensitivity of conventional endoscopy with white-light imaging (C-WLI) in diagnosis of early gastric cancers (EGCs) is merely 40%. Magnifying image-enhanced endoscopy (IEE) techniques such as magnifying narrow band imaging (M-NBI) have been developed and 2 RCT report that white-light imaging combine with M-NBI can increase the sensitivity to 95%. The strategy that using white-light imaging to detect the suspicious lesion and using M-IEE techniques to make a diagnosis of early gastric cancer is recommend in screening endoscopy.

    Optical enhancement (OE) which is one of the M-IEE techniques was developed by HOYA Co. (Tokyo, Japan) . This technology combines digital signal processing and optical filterers to clear display of mucosal microsurface (MS) and microvessel (MV). The advantage of OE is to overcome the darkness of NBI which leads to less usefulness for detect-ability in the full extended gastrointestinal lumen.Nevertheless, it is difficult to differentiate early gastric cancer from noncancerous lesions for beginner, and expertise with sub-optimal inter-observer agreement is essential for the use of M-IEE.

    Nowadays, Artificial intelligence (AI) using deep machine learning has made a major breakthrough in gastroenterology, which using gradient descent method and backpropagation to automatically extract specific images features. The diagnostic accuracy in identifying upper gastrointestinal cancer was 0.955 in C-WLI . Polyps can be identified in real time with 96% accuracy in screening colonoscopy. AI show an outstanding application in detection and diagnosis.

    This study aims to develop a M-OE assistance model in the diagnosis of EGCs by distinguishing cancer or not.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Application of Artificial Intelligence for Early Diagnosis of Gastric Cancer During Optical Enhancement Magnifying Endoscopy
    Actual Study Start Date :
    Jul 10, 2020
    Anticipated Primary Completion Date :
    Nov 30, 2020
    Anticipated Study Completion Date :
    Dec 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Patients who need undergo magnifying endoscopy

    Outcome Measures

    Primary Outcome Measures

    1. the diagnosis efficiency of the computer-assist diagnosis tool [12 months]

      the sensitivity, specificity and accuracy of the computer-assist diagnosis tool

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients receive optical magnifying OE endoscopy examination
    Exclusion Criteria:
    • Patients with advanced cancer, lymphoma,active stage of ulcer and artificial ulcer after ESD were excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Shandong University

    Investigators

    • Principal Investigator: Yanqing Li, PHD, Study Principal Investigator Qilu Hospital, Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanqing Li, Vice president of Qilu Hospital, Shandong University
    ClinicalTrials.gov Identifier:
    NCT04563416
    Other Study ID Numbers:
    • 2018SDU-QILU-3
    First Posted:
    Sep 24, 2020
    Last Update Posted:
    Sep 24, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 24, 2020