Gastric Subepithelial Tumors
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The nCLE interpretation criteria for the characterization of gastric subepithelial tumors with histopathological correlation | 24 months |
| The feasibility, safety and diagnostic yield of nCLE for gastric subepithelial tumors | 24 months |
Countries
China
Outcome results
None listed