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| Name | Class |
|---|---|
| American College of Gastroenterology | OTHER |
| The National Pancreas Foundation | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of PCL diagnosis | 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. | 48 months |
| Accuracy of risk-stratification of IPMNs | Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Imaging quality | Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions | 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects for this study will be identified from patients referred for diagnostic EUS-FNA of PCLs for a non-study indication by a physician responsible for their care (i.e., gastroenterologists, oncologists, general internists, and surgeons) either at the primary study center.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Fry | Contact | 614-293-1056 | Megan.Fry@osumc.edu | |
| Diana Burke | Contact | Diana.Burke@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Somashekar Krishna, MD, MPH | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale Campus | Recruiting | Scottsdale | Arizona | 85259 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33039474 | Derived | Firkins SA, Chen W, Krishna SG. Morphologic and Microscopic Characterization of an Unusual Pancreatic Cystic Lesion. Gastroenterology. 2021 May;160(6):e14-e16. doi: 10.1053/j.gastro.2020.09.046. Epub 2020 Oct 8. No abstract available. |
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Pancreas cyst fluid from EUS-nCLE
| Stanford Hospital | Recruiting | Stanford | California | 94305 | United States |
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| Yale School of Medicine | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Parkview Hospital Randallia | Active, not recruiting | Fort Wayne | Indiana | 46805 | United States |
| The Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| NYU Langone Health | Recruiting | Garden City | New York | 11530 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
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