Protocol No.EA2185
Principal InvestigatorAbbott, Daniel
PhaseN/A
Age GroupAdult
ClinicalTrials.GovNCT04239573 (Click to jump to clinicaltrials.gov)
Management Group(s) Gastrointestinal; _External Institution(s)

Title
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers

Description
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

Objective
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The doctors want to see if less frequent monitoring is better or worse than more frequent monitoring for patients with pancreatic cysts

Treatment
Group 1

In this group, you will get less frequent monitoring. You will receive an MRI or CT imaging scan at the beginning of the study and repeat the scan 1 year after joining the study. If the scans show normal results, you will repeat the scans every 2 years. The preference is for you to get scans using the same method each time. If the scans show abnormal results, you will receive an EUS.

Group 2

In this group, you will get more frequent monitoring. You will receive an MRI or CT imaging scan at the beginning of the study. The timing of future scans will depend on the size of your pancreatic cyst. The frequency of repeat imaging could range from every 6 months to every 2 years. The preference is for you to get scans using the same method each time

Key Eligibility
Must be age greater than or equal to 50 years and less than or equal to 75 years

Must have an ECOG Performance Status 0-1

Must not have acute pancreatitis or a history of chronic pancreatitis

Must have received a CT or MRI within 3 months of registration that revealed a newly identified greater than or equal to 1 cm pancreatic cyst

Women of childbearing potential must not be known to be pregnant

Must not have a prior diagnosis of pancreatic cyst or pancreatic malignancy of any type

Must not have a history of pancreatic resection

Must not have other asymptomatic pancreatic cystic lesion with zero/low malignancy potential (pancreatic pseudocyst, classic serous cystic lesion) on index CT or MRI

Must not have a family history of pancreatic adenocarcinoma in 1 or more first degree relatives

Must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct greater than 10mm, cyst causing obstructive jaundice)

Must not have a comorbid illness that precludes pancreatic cyst resection

Must not be participating in an already established surveillance program

Applicable Disease Sites
Pancreas

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital