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Confocal Endomicroscopy of Pancreatic InVivo

This study has been completed.
Sponsor:
Collaborator:
Mauna Kea Technologies
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01035008
First received: December 4, 2009
Last updated: October 19, 2012
Last verified: October 2012

December 4, 2009
October 19, 2012
December 2009
November 2011   (final data collection date for primary outcome measure)
Differentiate between non-mucinous, mucinous non-malignant & malignant pancreatic cysts in vivo [ Time Frame: One day (completion of the EUS) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035008 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Confocal Endomicroscopy of Pancreatic InVivo
Detection of Neoplastic Pancreatic Cysts Using Probe Based Confocal Laser Endomicroscopy: A Prospective in Vivo Study

Confocal laser endomicroscopy (CLE) is a novel and highly promising imaging method for that allows in vivo imaging of the mucosal layer at resolution of approximately 1 micron. Cellular and sub-cellular structures as well as capillaries and single red blood cells can be visualized. CLE is now well established as a highly accurate method for distinguishing neoplasia in the gastrointestinal tract lumen via endoscopy. A major new breakthrough is the development of sub-millimeter CLE probes that can be passed via an image guided needle (nCLE) into solid organs and cysts.

It is hypothesized that nCLE will help distinguish the benign, premalignant and malignant cystic lesions of pancreas by visualizing the cellular lining of the cysts, thereby, avoiding unnecessary surgery in patient with benign cysts and guiding to early and effective surgical removal of high risk neoplastic lesions.

A prototype minimal risk nCLE system has been developed that can be passed via standard endoscopic ultrasound needles into the pancreas but FDA clearance for in vivo use is not expected until late 2010. The investigators propose to evaluate this prototype nCLE system in vivo during endoscopic ultrasound (EUS), as an initial pilot study.

Hypothesis: the confocal laser endomicroscopy imaging of the nCLE can differentiate between non-mucinous, mucinous non- malignant and malignant pancreatic cysts in vivo and has increased sensitivity compared to endoscopic ultrasound-fine needle aspiration (EUS-FNA) tissue sampling. In this pilot study the investigators will primarily evaluate technical feasibility and interobserver agreement.

  1. In patients undergoing EUS for suspected pancreatic cysts, the investigators will evaluate the key nCLE image features of non mucinous, mucinous, and malignant pancreatic cystic neoplasms (PCN).
  2. The investigators will estimate the initial image quality, feasibility, and interobserver agreement of nCLE
  3. The investigators will establish the preliminary accuracy of nCLE to be used for planning a larger comparative trial
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pancreatic Cysts
Procedure: Endoscopic Ultrasound (EUS)
The investigators will do the standard EUS procedure. If a cyst is seen in the pancreas during EUS, the investigators will administer a special dye called fluorescein through the IV, and then use the new fiber-shaped microscope to take pictures of the lining of the cysts.
Other Names:
  • Cellvizio Endomicroscopy
  • Confocal
  • Endoscopic Ultrasound
Experimental: Diagnostic
The investigators are testing a new method called confocal laser endomicroscopy to see if it can detect pre-cancerous abnormalities in the lining of the cysts found in your pancreas. This will involve using a very thin fiber-shaped microscope which will be passed through a needle during the EUS procedure.
Intervention: Procedure: Endoscopic Ultrasound (EUS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing endoscopic ultrasound for evaluation of pancreatic cysts (including pseudocysts and suspected pancreatic cystic neoplasms) in the gastrointestinal (GI) lab at Mayo Clinic Jacksonville.

Exclusion Criteria:

  • Unwilling/unable to consent;
  • Solid pancreatic mass on computerized axial tomography/magnetic resonance (CT/MR);
  • Allergy to Fluorescein;
  • Pregnancy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01035008
09-006345
Yes
Michael B. Wallace, MD MPH, Mayo Clinic
Mayo Clinic
Mauna Kea Technologies
Principal Investigator: Michael B. Wallace, MD Mayo Clinic Florida
Mayo Clinic
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP