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

Confocal Laser Endomicroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459428
• Other study ID #: 2022-SDU-QILU-108
• Status: Recruiting
• Start date: May 20, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2022
• Source: Shandong University
• Contact: Yanqing Li, MD, PhD
• Phone: 0531182169385
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged 40-80 years undergoing the confocal laser endomicroscopy examination

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

Related Conditions & MeSH terms

• Confocal Laser Endomicroscopy
• Intestinal Metaplasia of Gastric Mucosa
• Metaplasia

Locations

Country	Name	City	State
China	Department of Gastroenterology, QiLu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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.	2 years
Primary	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.	2 years
Primary	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.	2 years
Primary	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.	2 years
Primary	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.	2 years
Secondary	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	2 years