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

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ClinicalTrials.gov Identifier: NCT01236300
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : March 31, 2015
Last Update Posted : June 8, 2016
Sponsor:
Collaborators:
Mauna Kea Technologies
Institut Paoli-Calmettes
Technische Universität München
Yale University
University of California, Irvine
Mayo Clinic
University of Washington
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Pancreatic Cysts Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cellvizio system Device: Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system



Primary Outcome Measures :
  1. Sensitivity [ Time Frame: October 2011 ]

    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.


  2. Specificity [ Time Frame: October 2011 ]

    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.


  3. PPV (Positive Predictive Value) [ Time Frame: October 2011 ]

    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.


  4. NPV (Negative Predictive Value) [ Time Frame: October 2011 ]

    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.



Secondary Outcome Measures :
  1. Overall Complication Rate [ Time Frame: August 2011 ]
    Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236300


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, IL 60637
Sponsors and Collaborators
University of Chicago
Mauna Kea Technologies
Institut Paoli-Calmettes
Technische Universität München
Yale University
University of California, Irvine
Mayo Clinic
University of Washington
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Irving Waxman, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01236300     History of Changes
Other Study ID Numbers: MKT-2010-INSPECT
EUSFNA_02 ( Other Identifier: Mauna Kea Technologies )
First Posted: November 8, 2010    Key Record Dates
Results First Posted: March 31, 2015
Last Update Posted: June 8, 2016
Last Verified: May 2016

Keywords provided by University of Chicago:
Pancreatic cysts

Additional relevant MeSH terms:
Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Gastrointestinal Agents