Clinical trial NCT02936986: Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Diagnosis of Gastric Subepithelial Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Subepithelial Tumors
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients undergoing EUS for the diagnosis of gastric subepithelial tumors will be recruited in this study at Qilu Hospital, 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.


Eligibility 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
citation: Zhang 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.