The Clinical,Radiologic,Pathologic and Molecular Marker Characteristics of Pancreatic Cysts Study

This combined cross-sectional and prospective single center clinical and translational study
involves a collaborative multidisciplinary team composed of gastroenterologists, surgeons,
radiologists, and basic scientists. Eligible patients with solitary or multiple pancreatic
cysts referred for diagnostic evaluation and/or surgical treatment will undergo initial
radiographic imaging with high-resolution CT, MRI/MRCP, and EUS/FNA as part of standard
medical care at Johns Hopkins Hospital. This is a three-phase study.

In Phase I, eligible patients with pancreatic cysts will undergo initial radiographic imaging
(high-resolution CT, MRI/MRCP, endoscopic ultrasonography (EUS) with fine needle aspiration
(FNA)) as part of standard care at the Johns Hopkins Hospital. Patients will be categorized
according to the presence of symptoms referable to the cyst or imaging features concerning
for malignancy based on the initial radiographic assessment. Symptomatic patients, or those
with concerning features, will be referred for surgical resection. The pathologic features
and final diagnosis of resected pancreatic cysts will be compared with preoperative clinical,
radiologic, and cyst fluid test results.

Asymptomatic patients with low-risk features at baseline radiographic and endoscopic imaging
will enter Phase II. Patients will be followed on a prospective periodic surveillance
schedule according the consensus clinical guidelines with either CT or MRI to monitor for new
or metachronous cystic neoplasms. Those who develop symptoms or concerning features will have
a repeat EUS/FNA as well as imaging with the opposite axial imaging modality, and will be
referred for surgery if a suspicious lesion is detected.

Patients who have surgery either during Phase I or Phase II, will enter post-surgical
surveillance (Phase III). Patients will be followed using a prospective periodic surveillance
schedule according the consensus clinical guidelines with either CT or MRI to monitor for new
or metachronous cystic neoplasms. Those who undergo surgery after surveillance in Phase II
will continue with the imaging modality they were originally evaluated with prior to
surgery.. Patients who develop symptoms or high-risk features on imaging will have a repeat
EUS/FNA as well as imaging with the opposite axial imaging modality and will be referred for
surgery if a suspicious lesion is detected. Samples will be collected prospectively for
biomarker analysis. Cyst fluid, pancreatic juice and blood will be collected during EUS and
blood will be collected yearly during the outpatient clinic visit. Patients will be followed
for three years.

Inclusion Criteria:

1. Adult patients age 18 years and older

2. Referred for assessment of one or more pancreatic cyst.

Exclusion Criteria:

1. Medically ill patients with ASA class 4 or greater.

2. History of chronic kidney disease with a serum creatinine > 2.0 mg/dl or estimated
glomerulofiltration rate (eGFR) < 30 ml/min, dialysis patients, acute renal failure,
cirrhosis of the liver, chronic hepatitis, prior nephrectomy or kidney or liver
transplantation.

3. History of moderate (generalized hives) or severe (facial swelling, airway reaction)
reaction to intravenous radiographic contrast material.

4. History of obstruction in the upper GI tract such as esophageal or pyloric stricture,
which would not allow passage of an endoscope.

5. Bleeding diathesis (clotting problems) or a history of thrombocytopenia (low platelet
count <50,000).

6. Inability to provide informed consent.

7. Pregnancy or lactation.