Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study
Completed
- Conditions
- Pancreatic Cysts
- Registration Number
- NCT01447238
- Lead Sponsor
- University of California, Irvine
- Brief Summary
The purpose of this study is to 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).
- Detailed Description
Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) From the date of imaging until follow up for 6 months to two years. Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California, Irvine Medical Center
🇺🇸Orange, California, United States