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Artificial Intelligence-assisted Confocal Laser Endomicroscopy Identification of Intestinal Metaplasia Severity

Sponsor
Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05462743
Collaborator
(none)
1,000
Enrollment
1
Location
18
Anticipated Duration (Months)
55.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently, the Correa cascade is a widely accepted model of gastric carcinogenesis. Intestinal metaplasia is a high risk factor for gastric cancer. According to Sydney criteria, mild intestinal metaplasia was not associated with gastric cancer, while moderate to severe intestinal metaplasia was strongly associated with the development of gastric cancer. Because intestinal metaplasia is distributed in various forms, the use of white light endoscopy lacks specificity, and the consistency with histopathological diagnosis is poor; Pathological biopsy is still needed to make a diagnosis. At present, national guidelines suggest that OLGIM score should be used to evaluate the risk of gastric cancer, and patients with OLGIM grade III/IV should be monitored by close gastroscopy. However, it requires at least four biopsies, which is clinically infeasible. Confocal laser endomicroscopy allows real-time observation of living tissue, comparable to pathological findings.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Gastric cancer is a common malignant tumor in digestive system diseases. Currently, the Correa cascade is a widely accepted model of gastric carcinogenesis. Intestinal metaplasia is a high risk factor for gastric cancer and is considered a precancerous condition of intestinal type gastric cancer. According to Sydney criteria, mild intestinal metaplasia was not associated with gastric cancer, while moderate to severe intestinal metaplasia was strongly associated with the development of gastric cancer. Because intestinal metaplasia is distributed in various forms, the use of white light endoscopy lacks specificity, and the consistency with histopathological diagnosis is poor; Pathological biopsy is still needed to make a diagnosis. At present, our national guidelines suggest that OLGIM score should be used to evaluate the risk of gastric cancer, and patients with OLGIM grade III/IV should be monitored by close gastroscopy. However, it requires at least four biopsies, which is clinically infeasible. Confocal laser endomicroscopy allows real-time observation of living tissue, comparable to pathological findings. Therefore, we established artificial intelligence-assisted confocal laser endoscope technology to determine the high risk of gastric cancer in real time, instead of tissue biopsy.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Artificial Intelligence-assisted Confocal Laser Endomicroscopy Identification of Intestinal Metaplasia Severity for Gastric Cancer Risk Assessment
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Dec 30, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    group for training the algorithm

    This group of images is used for training the algorithm of the artifical intelligence
    group for testing the algorithm

    This group of images is used for testing the algorithm of the artifical intelligence

    Outcome Measures

    Primary Outcome Measures

    1. Accuracy of AI model in assessing degree of intestinal metaplasia [2 years]

      Pathological biopsy results were used as the gold standard to assess the accuracy of the AI model in diagnosing the degree of intestinal metaplasia at the biopsy site

    2. Sensitivity of AI model to assess degree of intestinal metaplasia [2 years]

      The sensitivity of the AI model to diagnose the degree of intestinal metaplasia at the biopsy site was assessed using pathological biopsy results as the gold standard

    3. Specificity of AI model to assess degree of intestinal metaplasia [2 years]

      Pathological biopsy results were used as the gold standard to assess the specificity of the AI model in diagnosing the degree of intestinal metaplasia at the biopsy site

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged 18-80 years undergoing confocal gastroscopy
    Exclusion Criteria:

    • Patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy

    • Patients with previous surgical procedures on the stomach

    • Patients with contraindications to biopsy

    • Patients who refuse to sign the informed consent form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qilu Hospital, Shandong University Jinan Shandong China 250001

    Sponsors and Collaborators

    • Shandong University

    Investigators

    • Principal Investigator: Yanqing Li, 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:
    NCT05462743
    Other Study ID Numbers:
    • 2022-SDU-QILU-122
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Metaplasia

    Study Results

    No Results Posted as of Jul 18, 2022