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
- Diseases
- Gastric and esophageal cancer
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Naval Medical University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
- Establishment and Evaluation of a Probe-Based Confocal Laser Endomicroscopy Training System for Gastric Cancerous Lesions Diagnosis: Evidence From a National Training Program.Clin Transl Gastroenterol · 2026 · PMID 42508426
This page is information, not medical advice. Discuss any trial with your doctor.