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

NCT ID: NCT06981819

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-02

Study Completion Date

2025-11-13

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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pCLE by Experts ME-BLI pCLE by trainees

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Biotechnology Development Center

UNKNOWN

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Naval Medical University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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CLE Training

Identifier Type: -

Identifier Source: org_study_id