Pancreatic Cyst
Conditions
Keywords
Confocal laser endomicroscopy, pancreatic cancer, IPMN
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.
Interventions
None listed
Sponsors
American College of Gastroenterology
The National Pancreas Foundation
Ohio State University Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of PCL diagnosis | 48 months | Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia. |
| Accuracy of risk-stratification of IPMNs | 48 months | Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging quality | 48 months | Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions |
Countries
United States
Contacts
Primary ContactMegan Fry
Backup ContactDiana Burke
Outcome results
None listed