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

NCT06981819 | Completed

• 1 other identifier: CLE Training
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Confocal Laser Endomicroscopy; Gastric Neoplastic Lesions

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  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.

  From enrollment to obtaining the pathological results at 2 weeks

Secondary Outcomes (2)

• Other diagnostic performance outcomes

  From enrollment to obtaining the pathological results at 2 weeks

• Kappa value

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

Other Outcomes (1)

• Influencing factors of learning curve of pCLE

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

Interventions

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.

Also known as: 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.

Also known as: 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.

Also known as: pCLE by trainees

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead
• China Biotechnology Development Center: collaborator

Study Sites (1)

The First Affiliated Hospital of Naval Medical University

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gastric mucosal biopsy specimens or resected specimens

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 2, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 13, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)