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Establishment and Effectiveness Evaluation of a Training System for Confocal Laser Endomicroscopy

N

Naval Military Medical University

Status

Completed

Conditions

Gastritis
Gastric Cancer
Gastric Low-grade Intraepithelial Neoplasia
Gastric High-grade Intraepithelial Neoplasia

Treatments

Diagnostic Test: Probe-based Confocal Laser Endomicroscopy by Experts
Diagnostic Test: Probe-based Confocal Laser Endomicroscopy by trainees
Diagnostic Test: magnifying endoscopy with blue laser imaging

Study type

Observational

Funder types

Other

Identifiers

NCT06981819
CLE Training

Details and patient eligibility

About

Gastrointestinal endoscopy is a vital method for screening and diagnosing gastric cancer. It aids in identifying the tumor's location within the stomach and its macroscopic type, and allows biopsy for histological confirmation. Moreover, suspicious lesions can be further examined using specialized endoscopic techniques such as magnifying endoscopy (ME) combined with electronic staining, chromoendoscopy, confocal laser endomicroscopy (CLE) and fluorescence endoscopy. ME combined with electronic staining has been confirmed to achieve excellent diagnostic accuracy in distinguishing between noncancerous and cancerous lesions. However, ME is technically challenging, and gastric magnifying endoscopy involves various evaluation criteria such as the vessel plus surface classification system and Kudo's pit pattern classification, leading to a steep learning curve.

Confocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Despite having been available for approximately 20 years, and its accuracy in diagnosing gastric neoplastic lesions having been confirmed by several studies, the clinical application of CLE is not widespread, and there is a lack of relevant standards to guide the training of CLE endoscopists. To train more CLE endoscopists, we organized CLE training courses. We also evaluated the training's effectiveness and try to explore the Influencing factors of learning curve.

Enrollment

147 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • atients aged 18 to 85 years who were scheduled for detailed endoscopic examination at the First Affiliated Hospital of Naval Medical University were consecutively enrolled.

Exclusion criteria

  • nwillingness to undergo CLE examination
  • hypersensitivity to sodium fluorescein
  • hepatic or renal insufficiency

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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