Print

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

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

ArmDescriptionAssigned 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.
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT scan
    • tomography
  • Procedure: Endoscopic Ultrasound
    Undergo EUS
    Other names:
    • endosonography
    • EUS
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • nuclear magnetic resonance imaging
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
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.
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT scan
    • tomography
  • Procedure: Endoscopic Ultrasound
    Undergo EUS
    Other names:
    • endosonography
    • EUS
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • nuclear magnetic resonance imaging
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Site Public Contact
202-444-2223

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 .

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.