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EA2185, Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

Primary Investigator
Kwon, Richard
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT04239573
UM Number
2020.057
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Gastrointestinal Oncology
ID (Protocol)
19497
Secondary Protocol No
HUM00177414
Scope
National
Sponsor Type
National
Disease Site
Pancreas
Summary
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts.

Eligibility: Inclusion Criteria
  •   Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  •   Patient must not have acute pancreatitis or a history of chronic pancreatitis
  •   Patient must have received a computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months of registration that revealed a newly identified >= 1 cm pancreatic cyst
  •   Women of childbearing potential must not be known to be pregnant
  •   Patient must not have a prior diagnosis of pancreatic cyst or pancreatic malignancy of any type
  •   Patient must not have a history of pancreatic resection
  •   Patient must not have other asymptomatic pancreatic cystic lesion with zero/low malignancy potential (pancreatic pseudocyst, classic serous cystic lesion) on index CT or MRI
  •   Patient must not have a family history of pancreatic adenocarcinoma in 1 or more first degree relatives
  •   Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct > 10 mm, cyst causing obstructive jaundice)
  •   Patient must not have a comorbid illness that precludes pancreatic cyst resection
  •   Patient must not be participating in an already established surveillance program