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NCT Number: NCT06981819

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastric High-grade Intraepithelial Neoplasia Gastric Low-grade Intraepithelial Neoplasia Gastritis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Naval Medical University

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probe-based Confocal Laser Endomicroscopy by Experts

Diagnostic Test

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.

Other names: pCLE by Experts

magnifying endoscopy with blue laser imaging

Diagnostic Test

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.

Other names: ME-BLI

Probe-based Confocal Laser Endomicroscopy by trainees

Diagnostic Test

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.

Other names: pCLE by trainees

Primary outcomes

  1. Diagnostic Accuracy

    Time frame: From enrollment to obtaining the pathological results at 2 weeks

    Diagnostic accuracy in the research refers to the ability of diagnostic tests to correctly identify gastric cancerous or noncancerous lesions. gastric cancerous lesions included gastric high-grade intraepithelial neoplasia (HGIN), and gastric cancer. The calculation method for diagnostic accuracy is the percentage of cases where the diagnostic results are consistent with the pathological results out of the total number of cases.

Secondary outcomes

  1. Other diagnostic performance outcomes

    Time frame: From enrollment to obtaining the pathological results at 2 weeks

    Other diagnostic performance outcomes included diagnostic sensitivity, specificity, positive predictive value and negative predictive value.

  2. Kappa value

    Time frame: From the completion of the diagnosis of all cases to the end of calculating the Kapper value at one week.

    The Kappa value was used to evaluate the reliability or agreement between two diagnostic methods or two diagnostic results. In this study, the pathological results were used as the gold standard. The pCLE diagnosis results of each trainee were compared for consistency with the expert's pCLE results as well as the expert's ME-BLI diagnosis results using the Kapper value. The pCLE results and the ME-BLI diagnosis results provided by the experts also need to be compared for consistency using the Kapper value.

Other outcomes

  1. Influencing factors of learning curve of pCLE

    Time frame: From the complete the diagnosis by all the trainees to completion the factor analysis at 2 weeks

    We try to explore the Influencing factors of learning curve of pCLE in this research. To investigate factors that might influence the learning curve of pCLE, several factors were taken into account, including professional title, hospital level, number of endoscopic cases, number of ME cases, and duration of ME usage.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • China Biotechnology Development Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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