Comparing Two Methods to Follow Patients With Pancreatic Cysts

  • STATUS
    Recruiting
  • End date
    Dec 1, 2027
  • participants needed
    4606
  • sponsor
    ECOG-ACRIN Cancer Research Group
Updated on 24 March 2022
endoscopic ultrasound
pancreatic adenocarcinoma
adenocarcinoma
pancreatitis
pancreatic resection

Summary

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.

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 .

Details
Condition Pancreatic Carcinoma
Treatment questionnaire administration, quality-of-life assessment, computed tomography, magnetic resonance imaging, Endoscopic Ultrasound
Clinical Study IdentifierNCT04239573
SponsorECOG-ACRIN Cancer Research Group
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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