Comparing Two Methods to Follow Patients With Pancreatic Cysts
Purpose
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.
Condition
- Pancreatic Carcinoma
Eligibility
- Eligible Ages
- Between 50 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 component in cyst, pancreatic
duct ≥10mm, cyst causing obstructive jaundice).
- Patient must not have a comorbid illness that precludes pancreatic cyst resection.
- Patient must not be participating in any form of pancreatic cyst surveillance.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm I (low intensity surveillance) |
Patients undergo MRI or CT at the beginning of the trial and again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. |
|
|
Experimental Arm II (high intensity surveillance) |
Patients undergo MRI or CT. Patients with 1-2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with 2-3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst > 3 cm undergo EUS within 6 months, and if EUS is negative, patients undergo alternate MRI or CT with EUS every 3-6 months. |
|
Recruiting Locations
Cleveland, Ohio 44109
More Details
- Status
- Recruiting
- Sponsor
- ECOG-ACRIN Cancer Research Group
Study Contact
Detailed Description
PRIMARY OBJECTIVES: I. To compare the rates of unfavorable clinical outcomes in the two arms. SECONDARY OBJECTIVES: 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. EXPLORATORY OBJECTIVE: I. To evaluate and compare the predictive accuracy of known and future radiomic markers for dysplasia and pancreatic cancer. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A (LOW INTENSITY SURVEILLANCE): Patients undergo magnetic resonance imaging (MRI) or computed tomography (CT) at the beginning of the trial and again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative endoscopic ultrasound (EUS), repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. ARM B (HIGH INTENSITY SURVEILLANCE): Patients undergo MRI or CT. Patients with 1-2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with 2-3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst > 3 cm undergo EUS within 6 months, and if EUS is negative, patients undergo alternate MRI or CT with EUS every 3-6 months. After completion of imaging procedures, patients are followed up for 5 years from the date of registration .