In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors (INSPECT)

The University of Chicago

Status: Completed

Conditions: Pancreatic Cysts

Treatments: Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01236300

EUSFNA_02 (Other Identifier)

MKT-2010-INSPECT

Details and patient eligibility

About

Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinous cysts)

Full description

The primary aim of the study is to define interpretation criteria to differentiate mucinous from non-mucinous cysts and classify more precisely the cysts. Once these criteria have been defined, the diagnostic parameters of nCLE in differentiating the different types of cysts and the reproducibility of these criteria will be assessed.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for an EUSFNA procedure of a pancreatic cyst,
• Patients aged 18 years or older,
• Patients is under surgical consideration for management of the cyst
• Patients have provided written informed consent for the study

Exclusion criteria

• Allergy to fluorescein
• Pregnancy or breast-feeding

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Cellvizio system

Experimental group

Treatment:

Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system