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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-05-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Pancreatic Cysts

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cellvizio system

Group Type EXPERIMENTAL

Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system

Intervention Type DEVICE

Interventions

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Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system

Intervention Type DEVICE

Eligibility Criteria

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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