Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05462743
Enrollment
1000
Registered
2022-07-18
Start date
2022-07-01
Completion date
2023-12-30
Last updated
2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Confocal Laser Endomicroscopy, Intestinal Metaplasia

Brief 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.

Interventions

None listed

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 18-80 years undergoing confocal gastroscopy

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of AI model in assessing degree of intestinal metaplasia2 yearsPathological biopsy results were used as the gold standard to assess the accuracy of the AI model in diagnosing the degree of intestinal metaplasia at the biopsy site
Sensitivity of AI model to assess degree of intestinal metaplasia2 yearsThe sensitivity of the AI model to diagnose the degree of intestinal metaplasia at the biopsy site was assessed using pathological biopsy results as the gold standard
Specificity of AI model to assess degree of intestinal metaplasia2 yearsPathological biopsy results were used as the gold standard to assess the specificity of the AI model in diagnosing the degree of intestinal metaplasia at the biopsy site

Countries

China

Contacts

Primary ContactYanqing Li
liyanqing@sdu.edu.cn053182169385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026