Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric High-grade Intraepithelial Neoplasia | — | UNRESOLVED | — |
| Gastric Low-grade Intraepithelial Neoplasia | — | UNRESOLVED | — |
| Gastritis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| magnifying endoscopy with blue laser imaging | Diagnostic Test | — | UNRESOLVED |
| Probe-based Confocal Laser Endomicroscopy by Experts | Diagnostic Test | — | UNRESOLVED |
| Probe-based Confocal Laser Endomicroscopy by trainees | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic Accuracy
- timeFrame
- From enrollment to obtaining the pathological results at 2 weeks
- description
- 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 (2)
- measure
- Other diagnostic performance outcomes
- timeFrame
- From enrollment to obtaining the pathological results at 2 weeks
- description
- Other diagnostic performance outcomes included diagnostic sensitivity, specificity, positive predictive value and negative predictive value.
- measure
- Kappa value
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPan P, Gao J, Zhang Y, Pan JY, Zhang WH, Wang NN, Zhao JL, Dong ZX, Xiao ZH, Jin ZD, Li ZS, Bai Y. 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 Jul 27. doi: 10.14309/ctg.0000000000001074. Online ahead of print. PMID 42508426