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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
History of Changes
  Purpose

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.


Condition Intervention
Pancreatic Cysts
 Procedure: Endoscopic Ultrasound (EUS)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection of Neoplastic Pancreatic Cysts Using Probe Based Confocal Laser Endomicroscopy: A Prospective in Vivo Study

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: December 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035008

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Mauna Kea Technologies
Investigators
Principal Investigator: Michael B. Wallace, MD Mayo Clinic Florida
  More Information

No publications provided

Responsible Party: Michael B. Wallace, MD MPH, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01035008     History of Changes
Other Study ID Numbers: 09-006345
Study First Received: December 4, 2009
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
pancreatic cysts

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

ClinicalTrials.gov processed this record on June 18, 2013