Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors

Shandong University

Status: Completed

Conditions: Gastric Subepithelial Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT02936986

2016SDU-QILU-21

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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