By David Weinberg, MD, MSc

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 original purpose of the EA2185 study was to compare the clinical impact and cost effectiveness of two common surveillance strategies, one more frequent (the 2012 Fukuoka guidelines) and one less frequent (the 2015 American Gastroenterological Association [AGA] evidence-based guidelines).

Since the study first opened in 2020, evidence has emerged that both surveillance strategies are comparable in terms of clinical effectiveness. Though uncertainty about cost effectiveness remains, a trial dedicated solely to comparing the clinical impact of the two strategies is less necessary than it once was. Because of this, EA2185 has been redesigned as a biomarker-driven study with a new primary aim. Now, researchers are assessing the utility of blood-based and/or radiomic markers to identify patients at elevated risk for malignant degeneration of their pancreatic cysts.

Importantly, new participants in the study will no longer be randomized to one of the two surveillance strategies. Instead, their treating physician may select whichever strategy they believe most appropriate, as long as it meets the minimum study requirement (which mirrors the AGA guidelines). All new enrollees will undergo mandatory blood collection, which was previously optional, in addition to imaging collection.

Please see below for a summary of additional changes to the protocol with recently activated amendments #5 and #6:

• Significant updates have been made throughout the protocol to reflect different requirements for patients enrolled pre– and post–amendment #5 activation
• Patients who were enrolled before activation of amendment #5 must be reconsented and should continue to follow the prior protocol instructions
  • These patients will continue to follow the surveillance schedule per prior randomization, complete patient-reported outcomes per amendment #4, and provide optional (per prior consent) and mandatory imaging and specimen submissions
  • Instructions that apply only to enrollments prior to amendment #5 have been moved to Appendix IV
• Amendment #5 requirements will apply only to newly registered patients
  • Participants will no longer be randomized, and treating providers may dictate surveillance (as long as it meets the minimum study requirement)
  • No changes have been made to the eligibility criteria
  • Blood and imaging submissions are now mandatory for new enrollments, in addition to previous requirements
• Amendment #6 includes only minor administrative updates

The new primary endpoint of the study is to assess the time until worrisome features and/or high-risk stigmata develop, measured as time since enrollment. The trial plans to enroll 750 patients, all of whom will be followed for approximately 5 years from the date of randomization.

Learn more about EA2185 at ecog-acrin.org.

Dr. Weinberg (Fox Chase Cancer Center) is the study chair for this trial.

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 (Cleveland Clinic).