An observational study in Intestinal Metaplasia of Gastric Mucosa and Confocal Laser Endomicroscopy, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Shandong University · Observational
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.
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.
99 studies on the registry are indexed under Metaplasia; 12 are open to participants now.
This study's planned enrollment of 250 is close to the median of 253 across 48 observational studies indexed under Metaplasia.
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People at high risk of developing stomach cancer
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Get pictures and Videos from gastric antrum body and angle by confocal laser endomicroscopy in order to calculate the CGGIM score.
Get pictures and Videos from gastric antrum body and angle by Artificial intelligence in order to calculate the CGGIM score.
Endoscopists concluded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV
The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated to be compared with OLGIM based on the results of the endoscopist 's procedure.
Time frame: 2 years
Endoscopists derive the specificity of CGGIM score in the diagnosis of OLGIM III/IV
The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated to be compared with OLGIM based on the results of the endoscopist 's procedure.
Time frame: 2 years
Accuracy of CGGIM Score for Diagnosing OLGIM III/IV by Endoscopists
The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated to be compared with OLGIM based on the results of the endoscopist 's procedure.
Time frame: 2 years
AI yielded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV
The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated based on existing AI model identification results and compared with OLGIM.
Time frame: 2 years
AI yielded the specificity of CGGIM score in the diagnosis of OLGIM III/IV
The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated based on existing AI model identification results and compared with OLGIM.
Time frame: 2 years
AI yields accuracy of CGGIM score for diagnosis of OLGIM III/IV
The confocal grading of gastric intestinal metaplasia (CGGIM) may be used to assess a patient's risk by the endoscopic assessment of IM in the antrum, incisura, and corpus with the use of confocal laser endomicroscopy. The minimum score is 0 and the maximum score is 10. The higher the score, the more severe the degree of intestinal metaplasia, and the higher the risk of gastric cancer in patients. CGGIM scores were calculated based on existing AI model identification results and compared with OLGIM.
Time frame: 2 years
Comparison of accuracy of CGGIM score between AI and endoscopists in diagnosing OLGIM III/IV
Chi-square test was used to compare the accuracy of endoscopists and AI in the diagnosis of OLGIM
Time frame: 2 years
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Shandong University