Fact CheckerSign in

NCT06981819Completed

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

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

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
147 (actual)
First submitted
13 May 2025
Start date
2 Jun 2025
Primary completion date
31 Oct 2025
Lead sponsor
Changhai Hospital
NCT number
NCT06981819

What you commit to

  • Study type: Observational
  • Participants enrolled: 147
  • From 2 Jun 2025 to the primary completion date, 31 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • hepatic or renal insufficiency

Lab values

  • hypersensitivity to sodium fluorescein

Other

  • nwillingness to undergo CLE examination

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Naval Medical University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.