Spots Global Cancer Trial Database for Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
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Trial Identification
Brief Title: Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Official Title: Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Study ID: NCT03492151
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Scottsdale Campus, Scottsdale, Arizona, United States
Stanford Hospital, Stanford, California, United States
Yale School of Medicine, New Haven, Connecticut, United States
Parkview Hospital Randallia, Fort Wayne, Indiana, United States
The Johns Hopkins Hospital, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
NYU Langone Health, Garden City, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Baylor College of Medicine, Houston, Texas, United States
Contact Details
Name: Somashekar Krishna, MD, MPH
Affiliation: The Ohio State University Wexner Medical Center
Role: PRINCIPAL_INVESTIGATOR
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