Two Advocate Aurora Health hospitals have joined a clinical trial that aims to find the best approach for monitoring patients with benign (non-cancerous) pancreatic cysts.
The study, partially funded by the National Cancer Institute (NCI), part of the National Institutes of Health, will be conducted at Aurora St. Luke’s Medical Center in Milwaukee and Aurora BayCare Medical Center in Green Bay, Wisconsin.
Pancreatic cysts occur in up to 20 percent of the population and are more common in older adults. Not all pancreatic cysts are cancerous, but it is important to monitor all people with pancreatic cysts to watch for signs that they may be turning into a cancerous tumor. Researchers want to find better ways to detect pancreatic cancer early since it is especially difficult to treat or cure.
“Some pancreatic cysts are precursor lesions to pancreatic cancer,” said surgical oncologist Aaron Chevinsky, MD, Advocate Aurora Research Institute’s principal investigator for the study. “Although the risk of any one cyst becoming cancerous is low, the risk of pancreatic cancer to the person’s health is high. And, unfortunately, clinicians have not yet found a good way to predict which cysts might progress to cancer, as the clinical effectiveness of any pancreatic cyst surveillance strategy is unknown.”
The study aims to solve this problem by comparing two current yet differing sets of guidelines for how often clinicians should perform imaging tests to monitor pancreatic cysts greater than 1 cm in size. One guideline calls for more frequent imaging than the other. The trial’s purpose is to compare these two monitoring strategies and evaluate which one leads to better outcomes for patients.
“Millions of Americans have undergone or will undergo imaging for a pancreatic cyst,” said Amit Acharya, PhD, chief research officer and system vice president for Advocate Aurora Health and the Research Institute. “Without evidence to document the benefits and disadvantages of any surveillance strategy, millions of Americans are at risk for either over or under treatment and are potentially facing unnecessary medical expenses from costly imaging tests. The Research Institute is proud to support clinical trials such as this that will directly improve the care of our patients.”
Researchers aim to enroll nearly 4,600 participants nationwide and will randomly assign study participants in equal numbers to be followed using either the less frequent or more frequent surveillance strategy. In the less frequent group, patients will undergo an MRI or a CT every one to two years, depending upon any changes in the cyst. In the more frequent group, patients may receive, depending upon changes in the cyst, a recommendation to pursue an MRI or a CT anywhere from every three to six months to every two years. In both groups, specific changes in the cyst size or appearance will prompt an endoscopic ultrasound.
Researchers will follow all participants for five years. In cases where cancer is suspected, physicians may recommend that patients have a biopsy and possibly surgery.
“There are proponents of each pancreatic cyst surveillance strategy, but both sides agree on the need for a comparative study to provide a better understanding of what works,” Dr. Chevinsky said.
The study, “Comparing two methods to follow patients with pancreatic cysts,” or EA2185, is sponsored by the ECOG-ACRIN Cancer Research Group, which designs and conducts clinical trials under the sponsorship of NCI.
To learn more about Advocate Aurora’s research, visit aurora.org/research.
