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Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Recruiting
Trial ID: NCT03492151
Purpose
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.
Official Title
Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Stanford Investigator(s)
Samer Eldika
Clinical Professor, Medicine - Gastroenterology & Hepatology
Eligibility
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
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305