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Detection of Neoplastic Pancreatic Cysts Using Probe Based Confocal Laser Endomicroscopy: A Prospective in Vivo Study


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cysts

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Trial Information

Detection of Neoplastic Pancreatic Cysts Using Probe Based Confocal Laser Endomicroscopy: A Prospective in Vivo 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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Differentiate between non-mucinous, mucinous non-malignant & malignant pancreatic cysts in vivo

Outcome Time Frame:

One day (completion of the EUS)

Safety Issue:

No

Principal Investigator

Michael B. Wallace, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic Florida

Authority:

United States: Food and Drug Administration

Study ID:

09-006345

NCT ID:

NCT01035008

Start Date:

December 2009

Completion Date:

November 2011

Related Keywords:

  • Pancreatic Cysts
  • pancreatic cysts
  • Cysts
  • Pancreatic Cyst

Name

Location
Mayo Clinic Jacksonville, Florida  32224