Detection of Neoplastic Pancreatic Cysts Using Probe Based Confocal Laser Endomicroscopy: A Prospective in Vivo Study
18 Years
N/A
Both
Pancreatic Cysts
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 |
