Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions (CLIMB)

The Ohio State University

Status: Enrolling

Conditions: Pancreatic Cyst

Study type: Observational

Funder types: Other

Identifiers

NCT03492151

2017C0192

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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