Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors
Completed
- Conditions
- Gastric Subepithelial Tumors
- Registration Number
- NCT02936986
- Lead Sponsor
- Shandong University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China