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Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy in Solid Pancreatic Masses

Conditions
Solid Pancreatic Masses
Registration Number
NCT02936960
Lead Sponsor
Shandong University
Brief Summary

The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) 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 pancreatic masses, with histopathological correlation, and to perform the validation of these criteria.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
Inclusion Criteria
  • patients with any pancreatic mass
Exclusion Criteria
  • Patients aged <18 years or >80 years
  • Known allergy to fluorescein dye
  • Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
  • Pregnancy or breastfeeding
  • Inability to provide informed consent

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The nCLE interpretation criteria for the characterization of pancreatic masses with histopathological correlation20 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

🇨🇳

Jinan, Shandong, China

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