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Completed

NCT Number: NCT02936986

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

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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Key information

Conditions

Gastric Subepithelial Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2016
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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