NCT05462743

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Intestinal Metaplasia
• Artificial Intelligence
• Confocal Laser Endomicroscopy

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-07-18
• Last updated: 2022-07-18

Locations

1 site across 1 country: China