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Comparing two ways to monitor pancreatic cysts

Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers

Not applicable Interventional Eastern Cooperative Oncology Group · NCT04239573

This trial tests whether more frequent or less frequent imaging is better for people aged 50–75 who have one or more pancreatic cysts ≥1 cm.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment4606 (estimated)
Ages50 Years to 75 Years
SexAll
SponsorEastern Cooperative Oncology Group Research network
Locations352 sites (Birmingham, Alabama and 351 other locations)
Trial IDNCT04239573 on ClinicalTrials.gov

What this trial studies

This randomized trial assigns participants to either a lower-intensity surveillance schedule or a more frequent imaging schedule using MRI or CT, with endoscopic ultrasound (EUS) used when imaging shows concerning features. The primary outcome is the rate of unfavorable clinical outcomes between the two arms, and secondary outcomes include surgical morbidity/mortality, pancreatic cancer incidence, overall mortality, costs, healthcare utilization, quality of life, anxiety, financial distress, and non-adherence. The protocol includes comparison of known and future biomarkers and an exploratory analysis of radiomic markers to predict dysplasia or cancer. Eligible participants are adults 50–75 years old with at least one pancreatic cyst ≥1 cm on recent imaging and without high-risk features that would prompt immediate surgery.

Who should consider this trial

Good fit: Ideal candidates are people aged 50–75 with one or more pancreatic cysts ≥1 cm on recent CT, MRI, or EUS who do not have acute or chronic pancreatitis, prior pancreatic cancer or resection, high-risk cyst features, or a first-degree family history of pancreatic adenocarcinoma.

Not a fit: Patients with cysts that already show high-risk features requiring surgery, those with prior pancreatic cancer or resection, chronic pancreatitis, or a family history of pancreatic adenocarcinoma are unlikely to benefit from this surveillance comparison.

Why it matters

Potential benefit: If successful, the trial could identify a surveillance schedule that reduces unnecessary testing and costs while still catching cancers early enough to improve outcomes.

How similar studies have performed: Observational studies have described outcomes of pancreatic cyst surveillance, but randomized comparisons of surveillance intensity are limited and this trial addresses that gap.

Eligibility criteria

Show full inclusion / exclusion criteria 
* Patient must be ≥ 50 years and ≤ 75 years of age.
* 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.

Where this trial is running

Birmingham, Alabama and 351 other locations

+302 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.