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

Solid Pancreatic Masses Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936960
• Other study ID #: 2016SDU-QILU-20
• Status: Recruiting
• Phase: N/A
• First received: October 14, 2016
• Last updated: February 21, 2017
• Start date: May 2016

Study information

• Verified date: February 2017
• Source: Shandong University
• Contact: Yanqing Li, PhD. MD.
• Phone: 18678827666
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Solid Pancreatic Masses

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The nCLE interpretation criteria for the characterization of pancreatic masses with histopathological correlation		20 months