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


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cysts, Pancreatic Cancer

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Trial Information

The Clinical,Radiologic, Pathologic and Molecular Marker Characteristics of Premalignant and Malignant 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prevalence and incidence of malignant pancreatic cysts

Outcome Description:

1)to determine the prevalence and incidence of malignancy in pancreatic cysts according to cyst size and concerning features

Outcome Time Frame:

3-6 years

Safety Issue:

No

Principal Investigator

Anne Marie O'Broin-Lennon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

John Hopkins University, School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

NA_00026447

NCT ID:

NCT01202136

Start Date:

October 2012

Completion Date:

September 2016

Related Keywords:

  • Pancreatic Cysts
  • Pancreatic Cancer
  • pancreatic cyst
  • IPMN
  • PAN INs
  • Pancreatic cancer
  • pancreatic neoplasia
  • Cysts
  • Pancreatic Cyst
  • Pancreatic Neoplasms

Name

Location

Johns Hopkins MedicineBaltimore, Maryland  21287