NCT06981819

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

Establishment and Effectiveness Evaluation of a Training System for Confocal Laser Endomicroscopy in Diagnosing Gastric Neoplastic Lesions: A Prospective Diagnostic Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 147 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Probe-based Confocal Laser Endomicroscopy by Experts	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. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. To generate diagnostic results of pCLE, two pCLE experts dignosed independent. Any discrepancies are then resolved by a third expert.
DIAGNOSTIC_TEST	magnifying endoscopy with blue laser imaging	Magnifying Endoscopy with Blue Laser Imaging (ME-BLI) is an advanced endoscopic imaging technique that combines high-resolution magnification with laser-enhanced visualization to improve the detection and characterization of gastrointestinal (GI) mucosal lesions. Developed by Fujifilm, BLI utilizes specific laser wavelengths to enhance surface and vascular patterns, making it particularly useful for diagnosing early-stage cancers and precancerous conditions in the stomach, colon, and esophagus. To generate diagnostic results of ME-BLI, two ME-BLI experts dignosed independent. Any discrepancies are then resolved by a third expert.
DIAGNOSTIC_TEST	Probe-based Confocal Laser Endomicroscopy by trainees	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. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. The diagnosis results of CLE trainees are generated by each trainee themselves.

Timeline

• Start date: 2025-06-02
• Primary completion: 2025-10-31
• Completion: 2025-11-13
• First posted: 2025-05-21
• Last updated: 2025-12-16

Locations

1 site across 1 country: China