NCT05459428

Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk.

Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk: a Prospective Exploratory Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies.

Detailed description

Globally, gastric cancer is the fifth most prevalent malignancy and the third leading cause of cancer mortality. Current national guidelines recommend the use of OLGIM score to evaluate the risk of gastric cancer in patients, and close gastroscopic monitoring should be performed after OLGIM grade III/IV. However, it would not be clinically feasible to require at least four biopsies. Confocal laser endomicroscopy is able to magnify the tissue by 1000X, which can be seen at the cellular level. Observing goblet cells under Confocal laser endomicroscopy is simpler and diagnostic accuracy is comparable to pathology. Confocal laser endomicroscopy enables better assessment of intestinal metaplasia in gastric mucosa, thus quantifying the risk of gastric cancer and avoiding multiple biopsies. The investigators aim to design the CGGIM scores to evaluate gastric cancer risk.

Conditions

• Intestinal Metaplasia of Gastric Mucosa
• Confocal Laser Endomicroscopy

Timeline

• Start date: 2022-05-20
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-07-15
• Last updated: 2022-07-15

Locations

1 site across 1 country: China