Clinical trial NCT05459428: Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk.
Official title: Artificial Intelligence Confocal Laser Endomicroscopy for Real-time Assessment of Gastric Cancer Risk: a Prospective Exploratory Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal Metaplasia of Gastric Mucosa
Confocal Laser Endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People at high risk of developing stomach cancer

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Endoscopists concluded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV
timeFrame: 2 years
measure: Endoscopists derive the specificity of CGGIM score in the diagnosis of OLGIM III/IV
timeFrame: 2 years
measure: Accuracy of CGGIM Score for Diagnosing OLGIM III/IV by Endoscopists
timeFrame: 2 years
measure: AI yielded the sensitivity of CGGIM score in the diagnosis of OLGIM III/IV
timeFrame: 2 years
measure: AI yielded the specificity of CGGIM score in the diagnosis of OLGIM III/IV
timeFrame: 2 years
measure: AI yields accuracy of CGGIM score for diagnosis of OLGIM III/IV
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of accuracy of CGGIM score between AI and endoscopists in diagnosing OLGIM III/IV
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, QiLu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, MD, PhD
role: STUDY_CHAIR
References: