Clinical trial · Observational
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors
- 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)
The differential diagnosis of gastric subepithelial tumors by endoscopic ultrasound is currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe nCLE interpretation criteria for the characterization of gastric subepithelial tumors, with histopathological correlation, and to perform the validation of these criteria.
Conditions
Conditions (1)
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 Subepithelial Tumors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The nCLE interpretation criteria for the characterization of gastric subepithelial tumors with histopathological correlation
- timeFrame
- 24 months
- measure
- The feasibility, safety and diagnostic yield of nCLE for gastric subepithelial tumors
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Derivative study Inclusion Criteria: * patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 2 cm Exclusion Criteria: * Previous EUS-FNA performed within the past 3 months, and usual contraindications to EUS-FNA, such as serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function * Extramural structures, vascular lesions or cystic masses were visible by EUS * Pregnancy or breastfeeding * Known allergy to fluorescein sodium * Inability to provide informed consent Validation study Inclusion Criteria: * patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 1 cm Exclusion Criteria: * Previous EUS-FNA performed within the past 3 months, and usual contraindications to EUS-FNA, such as serous cardiopulmonary diseases, severe coagulopathy dysfunction, impaired kidney function * Extramural structures, vascular lesions cystic masses or lipoma were visible by EUS * Pregnancy or breastfeeding * Known allergy to fluorescein sodium * Inability to provide informed consent
References
Publications (1)
- DERIVEDZhang MM, Zhong N, Wang X, Li CQ, Ji R, Li Z, Gu X, Yu YB, Li LX, Zuo XL, Li YQ. Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy for diagnosis of gastric subepithelial tumors: a pilot study. Endoscopy. 2019 Jun;51(6):560-565. doi: 10.1055/a-0790-8436. Epub 2018 Dec 20. PMID 30572352