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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Artificial Intelligence-assisted Confocal Laser Endomicroscopy Identification of Intestinal Metaplasia Severity for Gastric Cancer Risk Assessment

Conditions
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Intestinal Metaplasia, Artificial Intelligence, Confocal Laser Endomicroscopy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group for training the algorithm<br>This group of images is used for training the algorithm of the artifical intelligence | |
| group for testing the algorithm<br>This group of images is used for testing the algorithm of the artifical intelligence | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of AI model in assessing degree of intestinal metaplasia | 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 years | 
| Sensitivity of AI model to assess degree of intestinal metaplasia | 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 | 2 years | 
| Specificity of AI model to assess degree of intestinal metaplasia | 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 | 2 years |