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.
Study Type
OBSERVATIONAL
Enrollment
500
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, United States
RECRUITINGStanford Hospital
Stanford, California, United States
RECRUITINGYale School of Medicine
New Haven, Connecticut, United States
RECRUITINGParkview Hospital Randallia
Fort Wayne, Indiana, United States
ACTIVE_NOT_RECRUITINGThe Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGNYU Langone Health
Garden City, New York, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGAccuracy of PCL diagnosis
Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.
Time frame: 48 months
Accuracy of risk-stratification of IPMNs
Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs
Time frame: 48 months
Imaging quality
Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions
Time frame: 48 months
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