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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cysts

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Trial Information

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


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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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)

Outcome Description:

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

Outcome Time Frame:

From the date of imaging until follow up for 6 months to two years.

Safety Issue:

Yes

Principal Investigator

Kenneth J Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine

Authority:

United States: Institutional Review Board

Study ID:

HS2010-7729

NCT ID:

NCT01447238

Start Date:

September 2010

Completion Date:

December 2012

Related Keywords:

  • Pancreatic Cysts
  • pancreatic cysts
  • EUS/FNA
  • Needle-based Confocal Laser Endomicroscopy (nCLE)
  • fiber optic imaging
  • EUS/FNA of pancreatic cysts
  • Cysts
  • Pancreatic Cyst

Name

Location

University of California, Irvine Medical CenterOrange, California  92868