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

Last updated: July 12, 2022
Sponsor: Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Precancerous Condition

Treatment

N/A

Clinical Study ID

NCT05459428
2022-SDU-QILU-108
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatricdisorders 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

Study Design

Total Participants: 250
Study Start date:
May 20, 2022
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Department of Gastroenterology, QiLu Hospital, Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

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