Clinical trial NCT06981819: Establishment and Effectiveness Evaluation of a Training System for Confocal Laser Endomicroscopy
Official title: Establishment and Effectiveness Evaluation of a Training System for Confocal Laser Endomicroscopy in Diagnosing Gastric Neoplastic Lesions: A Prospective Diagnostic Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Cancer
Gastric High-grade Intraepithelial Neoplasia
Gastric Low-grade Intraepithelial Neoplasia
Gastritis
Keywords: Confocal Laser Endomicroscopy
Gastric Neoplastic Lesions
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: China Biotechnology Development Center
First posted: 2025-05-21
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The use of detailed endoscopic examination includes the following scenarios: routine endoscopic examination suspected early cancer but the biopsy pathology only indicated precancerous lesions, preoperative examination for early upper gastrointestinal cancer endoscopic resection, follow-up after endoscopic resection of early upper gastrointestinal cancer and precancerous lesions, follow-up after partial gastrectomy for advanced gastric cancer.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: From enrollment to obtaining the pathological results at 2 weeks
Secondary outcomes:
measure: Other diagnostic performance outcomes
timeFrame: From enrollment to obtaining the pathological results at 2 weeks
measure: Kappa value
timeFrame: From the completion of the diagnosis of all cases to the end of calculating the Kapper value at one week.
Other outcomes:
measure: Influencing factors of learning curve of pCLE
timeFrame: From the complete the diagnosis by all the trainees to completion the factor analysis at 2 weeks
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