Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Recruiting now
Conditions studied: Pancreatic Cyst
In brief
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.
Key facts
- Study ID
- NCT03492151
- Run by
- Ohio State University Comprehensive Cancer Center
- People needed
- 500
- Starts
- 2018-10-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Baylor College of Medicine — Houston, Texas, United States (enrolling)
- Stanford Hospital — Stanford, California, United States (enrolling)
- Yale School of Medicine — New Haven, Connecticut, United States (enrolling)
- Mayo Clinic Scottsdale Campus — Scottsdale, Arizona, United States (enrolling)
- The Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- NYU Langone Health — Garden City, New York, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
- Parkview Hospital Randallia — Fort Wayne, Indiana, United States
Full record on ClinicalTrials.gov
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