EA2185 Study: Pancreatic Cyst Screening Comparing Two Methods to Follow Patients with Pancreatic Cysts

UVA Tracking #
HSR200057
Principal Investigator
Todd W Bauer
Contact
Jay Glick
Contact Phone
434.825.7907
Official Trial Title
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs
Study Description

UVa Cancer Center seeks people ages 50-75 who have been diagnosed with a pancreatic cyst by imaging or EUS in the past 6 months for a research study. The purpose of the study is to compare two standard methods of patient surveillance to determine which surveillance schedule is better for the patient.
• Both standard methods of surveillance include imaging such as MRI or CT scans, which are standard of care, as well as endoscopic ultrasound (also standard), if prompted by results of images to better visualize the cyst.
• The difference in the two standard methods of surveillance is the intensity of surveillance. One method is more intense, with more frequent visits; the second method is less intense, with less frequent visits.

You may be eligible for this study if: you are between the ages of 50 and 75, and have been diagnosed with a pancreatic cyst by imaging or EUS in the past 6 months. You are not eligible if you have a history of acute or chronic pancreatitis, have had pancreatic surgery or your immediate family has history of pancreatic cancer.

Study involves two groups: participants will be assigned to (random assignment per computer), and parallel one of the two standard surveillance methods.
In Group 1 (less frequent visits), you will undergo MRI or CT every 1-2 years depending upon any changes that might occur in the cyst.
o In Group 2 (more frequent visits), you will undergo MRI or CT every 6 months for 1 year. The timing of additional imaging will depend on the cyst size.
o In both groups, specific changes in the cyst size or appearance will prompt an endoscopic ultrasound* (EUS).
*EUS involves insertion of a thin tube into the mouth, down into the stomach and into the first part of the small intestine. At the tip of the tube is a small ultrasound probe that emits sound waves. These sound waves bounce off of the surrounding structures, and are then recaptured by the probe and converted into images that are interpreted by the doctor. Because the pancreas sits next to the stomach and small intestine, EUS allows the physician to get very detailed images of the pancreas. This procedure is done under sedation in an outpatient setting.

Participant’s insurance company will be billed for medication, tests and procedures

Compensation

None