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

December 15, 2025 updated by: Zhaoshen Li, Changhai Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • The First Affiliated Hospital of Naval Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to obtaining the pathological results at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to obtaining the pathological results at 2 weeks
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.
From the completion of the diagnosis of all cases to the end of calculating the Kapper value at one week.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the complete the diagnosis by all the trainees to completion the factor analysis at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

China Biotechnology Development Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

November 13, 2025

Study Registration Dates

First Submitted

May 13, 2025

First Submitted That Met QC Criteria

May 13, 2025

First Posted (Actual)

May 21, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLE Training

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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