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Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
Sponsor: Ohio State University Comprehensive Cancer Center · Participants: 500 · Started: Oct 1, 2018
Contact the study team
- Megan Fry · Phone: 614-293-1056
Official record on ClinicalTrials.gov — NCT03492151
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.