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

NCT02936986 | Completed DMC

• 1 other identifier: 2016SDU-QILU-21
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Subepithelial Tumors

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 2 cm

You may not qualify if:

• 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
• patients aged from 18 to 75 years, with gastric subepithelial tumors ≥ 1 cm
• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• 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.

  PMID: 30572352 DERIVED

Study Officials

• Yanqing Li, PhD. MD.

  Department of Gastroenterology, Qilu Hospital, Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Official Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 18, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

CN (1)