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Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy—A Pilot Study

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ClinicalTrials.gov Identifier: NCT01447238
Recruitment Status : Unknown
Verified October 2011 by Kenneth J. Chang, University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : October 6, 2011
Last Update Posted : October 6, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).

Condition or disease Intervention/treatment
Pancreatic Cysts Device: Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe

Detailed Description:
Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy—A Pilot Study
Study Start Date : September 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012
Groups and Cohorts

Intervention Details:
    Device: Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe

    Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional direct visualization (fiber optic probe) and nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure.

    The probes will be positioned against the lining of the pancreatic cyst, and images will be acquired. After imaging, fine needle aspiration of the lesion will be performed, as usual.

    Other Names:
    • Cellvizio
    • nCLE
    • Spyglass

Outcome Measures

Primary Outcome Measures :
  1. Assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE) [ Time Frame: From the date of imaging until follow up for 6 months to two years. ]
    Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients underoing EUS-FNA procedure for pancreatic cyst.
Criteria

Inclusion Criteria:

  • Patients scheduled for an EUS-FNA procedure of a pancreatic cyst,
  • Aged above 18 years
  • Granted written informed consent for the study can be included in the study.

Exclusion Criteria:

  • Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc)
  • Pregnant or breastfeeding
  • Allergy to fluorescein
  • Renal insufficiency
Contacts and Locations

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): NCT01447238


Contacts
Contact: Amy Tan 714-456-2215 amytan@uci.edu
Contact: Herlinda Bergman 714-456-7090 hbergman@uci.edu

Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Kenneth J Chang, MD University of California, Irvine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth J. Chang, Professor of Clinical Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01447238     History of Changes
Other Study ID Numbers: HS2010-7729
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: October 2011

Keywords provided by Kenneth J. Chang, University of California, Irvine:
pancreatic cysts
EUS/FNA
Needle-based Confocal Laser Endomicroscopy (nCLE)
fiber optic imaging
EUS/FNA of pancreatic cysts

Additional relevant MeSH terms:
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases