Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence | — | UNRESOLVED | — |
| Confocal Laser Endomicroscopy | — | UNRESOLVED | — |
| Intestinal Metaplasia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- group for training the algorithm
- description
- This group of images is used for training the algorithm of the artifical intelligence
- label
- group for testing the algorithm
- description
- This group of images is used for testing the algorithm of the artifical intelligence
Primary outcomes (3)
- measure
- Accuracy of AI model in assessing degree of intestinal metaplasia
- timeFrame
- 2 years
- description
- Pathological 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
- measure
- Sensitivity of AI model to assess degree of intestinal metaplasia
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available