An observational study in Intestinal Metaplasia, Artificial Intelligence and Confocal Laser Endomicroscopy, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Shandong University · Observational
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.
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.
Shandong University is the lead sponsor of 291 studies on the registry; 59 are open to participants now.
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Consecutive patients who receive the upper gastrointestinal tract pCLE examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study.
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This group of images is used for training the algorithm of the artifical intelligence
This group of images is used for testing the algorithm of the artifical intelligence
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
Time frame: 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
Time frame: 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
Time frame: 2 years
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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