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

S

Shandong University

Status

Enrolling

Conditions

Confocal Laser Endomicroscopy
Intestinal Metaplasia of Gastric Mucosa

Study type

Observational

Funder types

Other

Identifiers

NCT05459428
2022-SDU-QILU-108

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Confocal laser endomicroscopy scoring of the extent of intestinal metaplasia
Description:
Get pictures and Videos from gastric antrum body and angle by confocal laser endomicroscopy in order to calculate the CGGIM score.
Artificial intelligence scoring of the extent of intestinal metaplasia
Description:
Get pictures and Videos from gastric antrum body and angle by Artificial intelligence in order to calculate the CGGIM score.

Trial contacts and locations

1

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Central trial contact

Rui Ji, MD, PhD; Yanqing Li, MD, PhD

Data sourced from clinicaltrials.gov

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