Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Subepithelial Tumors
- Sponsor
- Shandong University
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- The nCLE interpretation criteria for the characterization of gastric subepithelial tumors with histopathological correlation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Yanqing Li
Official Title: Vice president of Qilu Hospital
Shandong University
Eligibility Criteria
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
Outcomes
Primary Outcomes
The nCLE interpretation criteria for the characterization of gastric subepithelial tumors with histopathological correlation
Time Frame: 24 months
The feasibility, safety and diagnostic yield of nCLE for gastric subepithelial tumors
Time Frame: 24 months