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NCT03492151Recruiting

Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

Ohio State University Comprehensive Cancer Center

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

Inclusion Criteria: * Patient age 18 years or older * All patients referred for EUS-FNA of accessible PCL where surgery is contemplated * Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies Exclusion Criteria: * Unable to obtain informed consent * Unable to tolerate the procedure * Women with known pregnancy at time of procedure * Patient age less than 18 years * Bleeding diathesis * Known allergy to fluorescein * Prior pancreatic cancer * Prior pancreatic surgery

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Conditions

Pancreatic Cyst

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