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

Study Overview
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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)

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.

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

Conditions
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Pancreatic Cysts

Intervention / Treatment
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* Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system


Participation Criteria
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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 Exclusion Criteria: Allergy to fluorescein Pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cellvizio system<br> | Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available. | October 2011 | 
| Specificity | Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available. | October 2011 | 
| PPV (Positive Predictive Value) | Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available. | October 2011 | 
| NPV (Negative Predictive Value) | Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2. For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review. In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients' clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available. | October 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Complication Rate | Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure | August 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cysts