Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs
- Study HIC#:2000027478
- Last Updated:07/15/2021
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.
- Start Date03/17/2021
- End Date12/01/2027
Trial Purpose and Description
I. To compare the rates of unfavorable clinical outcomes in the two arms.
I. To compare rates of major surgical morbidity and/or mortality between arms. II. To compare pancreatic cancer incidence and all-cause mortality across arms. III. Compare institutional (direct) costs. IV. Compare healthcare utilization of imaging, invasive testing, surgical, and other procedures across the two surveillance arms.
V. Compare patient (out-of-pocket and other indirect) costs. VI. Describe diagnostic test and treatment pathways by arm. VII. Compare patient reports of quality of life (QOL), situational anxiety. VIII. Compare patient report of financial distress. IX. Compare rates of non-adherence by arm assignment. X. To evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer.
- 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