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Clinical Trials/NCT02936960
NCT02936960
Unknown
Not Applicable

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

Shandong University1 site in 1 country30 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Solid Pancreatic Masses
Sponsor
Shandong University
Enrollment
30
Locations
1
Primary Endpoint
The nCLE interpretation criteria for the characterization of pancreatic masses with histopathological correlation
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
December 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shandong University
Responsible Party
Principal Investigator
Principal Investigator

Yanqing Li

Vice president of Qilu Hospital

Shandong University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The nCLE interpretation criteria for the characterization of pancreatic masses with histopathological correlation

Time Frame: 20 months

Study Sites (1)

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