EA 2185: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs (CTMS# 23-0165)
Lay Description
The primary goal of this study is to compare the clinical effectiveness and associated resource utilization of the Fukuoka and AGA guidelines for pancreatic cyst surveillance.
Category
- Cancers and Other Neoplasms
- Pancreatic Cancer (excluding Islets)
- IRB Number
- STUDY00000322
- NCT Number
- NCT # not yet entered
Eligibility
- Eligible Ages
- 50-75
- Eligible Genders
- ALL
- Accepts Healthy Volunteers
Inclusion Criteria
- Patient must be ≥ 50 years and ≤ 75 years of age.
- Patient must not have acute pancreatitis or a history of chronic pancreatitis.
- Patient must have received a CT, MRI, or EUS within 6 months prior to randomization that revealed one or more ≥ 1 cm pancreatic cyst (s).
- Patients of childbearing potential must not be known to be pregnant.
- Patient must not have a prior diagnosis of pancreatic malignancy of any type.
- Patient must not have a history of pancreatic resection.
- Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible.
- Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives(biological parents, full siblings or children).
- Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid ECOG-ACRIN EA2185 Cancer Research Group Version Date: May 25, 2023 18 component in cyst, pancreatic duct ≥10mm, cyst causing obstructive jaundice).
- Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection.
- Patient must not be currently participating in pancreatic cyst surveillance defined as organized, periodic up-to-date imaging directed towards the pancreatic cyst of interest.
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu
Jessica Villarreal
villarreal24@uthscsa.edu
Principal Investigator
Alexander Parikh