Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Start Date
10/1/2018
Completion Date
12/31/2026
Summary
The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.
Eligibility Criteria
Age Range: 18 years to No maximum
Conditions
Locations
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona 85259
United States
Stanford Hospital
Stanford, California 94305
United States
Yale School of Medicine
New Haven, Connecticut 06510
United States
Parkview Hospital Randallia
Fort Wayne, Indiana 46805
United States
The Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
NYU Langone Health
Garden City, New York 11530
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
Baylor College of Medicine
Houston, Texas 77030
United States