Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

Ways to Watch Pancreatic Cysts

M
Mohammad Al-Haddad, MD

Primary Investigator

Enrolling By Invitation
50 years - 75 years
All
Phase N/A
50 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at Indiana University Simon Comprehensive Cancer Center (IUSCCC), please contact the
IU Clinical Trials Office at 
Phone: (317) 278-5632

Detailed description of study

Patients are randomized to 1 of 2 arms:

  1. 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.
  2. 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 .

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Carcinoma, Cancer
  • Age: 50 years - 75 years
  • Gender: All

Inclusion criteria:

  •    Patient must not have acute pancreatitis or a history of chronic pancreatitis.
  •   Patient must have received a CT, MRI, or EUS within 6 months prior to randomization that revealed one or more ≥ 1 cm pancreatic cyst (s).
  •   Patients of childbearing potential must not be known to be pregnant.
  •   Patient must not have a prior diagnosis of pancreatic malignancy of any type.
  •   Patient must not have a history of pancreatic resection.
  •   Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible.
  •   Patient must not have a family history of pancreatic adenocarcinoma in one or more first degree relatives(biological parents, full siblings or children).
  •   Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥10mm, cyst causing      obstructive jaundice).
  •   Patient must not have a comorbid illness that precludes pancreatic cyst resection.
  •   Patient must not be participating in any form of pancreatic cyst surveillance.

This study investigates different ways to monitor pancreatic cysts, which are fluid-filled sacs that can form in the pancreas. The purpose of this study is to compare more frequent monitoring with less frequent monitoring to see which method leads to better outcomes for patients with pancreatic cysts.

Participants will be randomly assigned to one of two study arms. In the low intensity surveillance arm, patients will have MRI or CT scans at the start and then less frequently if no abnormalities are found. In the high intensity surveillance arm, patients will have more frequent MRI or CT scans, especially if the cysts are larger. Some patients may also have endoscopic ultrasounds, which is a test that uses a thin tube with a camera to look inside the body.

  • Who can participate: Adults with a pancreatic cyst measuring at least 1 cm, who have not had pancreatitis or pancreatic surgery, may be eligible. Participants should not have a family history of pancreatic cancer or other conditions that would need immediate surgery.
  • Study details: Participants will be assigned to either low or high intensity monitoring. They will undergo MRI or CT scans and possibly endoscopic ultrasounds to check their pancreatic cysts.
  • Study timelines: The study will last 5 years.
Updated on 23 Jun 2026. Study ID: GI-ECOG-EA2185, 19969, 21938
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only