Comparing Two Methods to Follow Patients With Pancreatic Cysts

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

Conditions
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Pancreatic Carcinoma

Intervention / Treatment
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* Procedure: Computed Tomography
* Procedure: Endoscopic Ultrasound
* Procedure: Magnetic Resonance Imaging
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (low intensity surveillance)<br>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<br>* Undergo CT<br>* Other names: tomography;Procedure: Endoscopic Ultrasound<br>* Undergo EUS<br>* Other names: EUS;Procedure: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: nuclear magnetic resonance imaging;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (high intensity surveillance)<br>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<br>* Undergo CT<br>* Other names: tomography;Procedure: Endoscopic Ultrasound<br>* Undergo EUS<br>* Other names: EUS;Procedure: Magnetic Resonance Imaging<br>* Undergo MRI<br>* Other names: nuclear magnetic resonance imaging;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of an unfavorable outcome | Defined as a composite of: (1) any pancreatic cancer without surgery; (2) unresectable pancreatic cancer or cancer > T1a, N0 at surgery, and (3) benign disease at surgery will be approached from the intent-to-treat perspective. Time to the first occurrence of the primary endpoint will measured from randomization. Survival analysis methods will be used to estimate and compare distributions of time to an unfavorable event between the study arms. In particular Kaplan-Meier estimates will be developed for each arm and a log rank test will be used to compare the two arms. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical and all-cause mortality | Rates of major surgical morbidity and/or mortality will be estimated and compared across arms. All-cause mortality will be estimated and compared between the arms using log rank tests. | Up to 5 years | 
| Major surgical morbidity | Rates of major surgical morbidity and/or mortality will be estimated and compared across arms. | Up to 5 years | 
| Pancreatic cancer incidence | Pancreatic-cancer incidence and pancreatic cancer specific mortality will be estimated and compared between the arms using log rank tests. | Up to 5 years | 
| Healthcare utilization of imaging, invasive testing, surgical, and other procedures using information collected from sites. | Will compare between two arms. | Up to 5 years | 
| Patient (out-of-pocket and other indirect) costs collected from patient surveys | Will compare between two arms. | Up to 5 years | 
| Patient reports of quality of life | Will be assessed by Patient Reported Outcomes Measurement Information System10. Will compare between arms. Longitudinal regression modelling will be completed to account for the repeated assessments over time. | Up to 5 years | 
| Patient reports of situational anxiety | Will be assessed by Patient Reported Outcomes Measurement Information System-Anxiety short form. Will compare between arms. | Up to 5 years | 
| Patient report of financial distress collected through patient surveys | Will compare between arms. | Up to 5 years | 
| Rates of non-adherence | Will compare rates of non-adherence by arm assignment. | Up to 5 years | 
| Biomarker analysis from collected samples to compare the predictive performance of known and future biomarkers for dysplasia or cancer | Will evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer. | Up to 5 years |