EA2185 Pancreatic Cyst Surveillance Study: Amendment #2 Highlights

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EA2185 Pancreatic Cyst Surveillance Study: Amendment #2 Highlights

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EA2185 – Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

The study chair for this trial is David Weinberg, MD, MSc (Fox Chase Cancer Center). The study co-chairs are Herbert Zeh, MD (UT Southwestern Medical Center), Paul Moayyedi, MD (McMaster University), James Scheiman, MD (University of Michigan), Hanna Zafar, MD, MHS (University of Pennsylvania), Aatur Singhi, MD, PhD (University of Pittsburgh), Stanley Hamilton, MD (City of Hope), Flavio Rocha, MD (Oregon Health & Science University), and Xin Yao, MD (ThedaCare Regional Cancer Center).

Pancreatic cysts are a common and often incidental finding on abdominal imaging. These cysts are important to monitor because a minority of them will transform into pancreatic cancer over time. The optimal long-term management strategy for these cysts is unknown, posing a challenge for patients and their physicians. Longitudinal surveillance of cysts is based on cross-sectional imaging and sometimes endoscopic ultrasound (EUS). The two primary surveillance strategies in clinical practice are the 2012 Fukuoka guidelines (from the 14th meeting of the International Association of Pancreatology in Fukuoka, Japan), and the 2015 American Gastroenterological Association (AGA) evidence-based guidelines. They vary in their recommendations about how often CT or MRI scans should be obtained, the indications for EUS, and the role of surgery.

The EA2185 study will compare these two surveillance programs from a clinical as well as a cost perspective to determine which approach is more effective. Participants will be randomized to either a more frequent (Fukuoka) or less frequent (AGA) surveillance strategy and followed for approximately five years. To be eligible for the study, patients must be between the ages of 50 and 75 and have one or more cysts that are 1 cm or greater. Patients must not currently be on any surveillance regimen or have a history of chronic pancreatitis or pancreatic cancer. A total of 4606 enrollments are planned.

Amendment #2 was recently activated to expand eligibility. Please see below for a summary of key changes to the protocol.

  • The baseline image window was expanded from 3 to 6 months (eligibility criteria 3.1.3)
  • If the baseline cyst was identified on an endoscopic ultrasound (EUS), the patient does not need a CT or MRI for enrollment; EUS must be within 6 months (eligibility criteria 3.1.3)
  • The amendment clarifies that prior pancreatic cysts are permitted if the patient is not in a pancreatic cyst surveillance program (eligibility criteria 3.1.11)

The amendment also clarifies that patients who have only pancreatic cysts with no malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible (eligibility criteria 3.1.7).

EA2185 is a multidisciplinary study involving radiologists, gastroenterologists, surgeons, medical oncologists and primary care physicians. Enrolling sites must be part of the National Clinical Trials Network (NCTN) but patient referrals can come from local sites that are not part of the NCTN. The medical management of the patient remains under the direction of the referring care provider. Surveillance imaging and/or endoscopic procedures can be performed in any setting as long as the data is available for the research team.

If you have any questions, or are interested in opening the study at your center, please contact EA2185@ecog-acrin.org.

Learn more about EA2185 at ecog-acrin.org.

Related article: Pancreatic Cysts Are Monitored in New Trial Aimed at Reducing Cancer Risk Through Targeted Screening, published by the National Cancer Institute.

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