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CompletedNCT02936986Updated Apr 30, 2018

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

An observational study in Gastric Subepithelial Tumors, sponsored by Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-30.

Sponsored by Shandong University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
94
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Gastric Subepithelial Tumors
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In context

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
94 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. The nCLE interpretation criteria for the characterization of gastric subepithelial tumors with histopathological correlation

    Time frame: 24 months

  2. The feasibility, safety and diagnostic yield of nCLE for gastric subepithelial tumors

    Time frame: 24 months

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Study locations

1 site
  • Department of Gastroenterology, Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
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References and documents

Publications

  • 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. PubMed 30572352 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02936986
Lead sponsor
Shandong University
Responsible party
Yanqing Li (Official Title: Vice president of Qilu Hospital, Shandong University) — Principal investigator
First posted
Oct 18, 2016
Start date
May 2016
Primary completion
Apr 2018
Completion
Apr 2018
Last update
Apr 30, 2018

Study contacts

Yanqing Li, PhD. MD.
study director · Department of Gastroenterology, Qilu Hospital, Shandong University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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