4606 Participants Needed

Monitoring Methods for Pancreatic Cyst

Recruiting at 382 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: ECOG-ACRIN Cancer Research Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is the monitoring method for pancreatic cysts safe for humans?

Endoscopic ultrasound (EUS) and fine-needle aspiration (FNA) are generally considered safe for evaluating pancreatic cysts, although there are some conflicting data about complication rates. Computed tomography (CT) and magnetic resonance imaging (MRI) are non-invasive imaging techniques that are widely used and considered safe for monitoring pancreatic cysts.12345

Is the monitoring of pancreatic cysts using CT scans, EUS, and MRI generally safe?

CT scans, EUS (endoscopic ultrasound), and MRI (magnetic resonance imaging) are generally considered safe methods for monitoring pancreatic cysts. EUS-guided procedures, like fine-needle aspiration, are also safe, though there may be some risk of complications.12356

How does this treatment for pancreatic cysts differ from other treatments?

This treatment uses advanced imaging techniques like CT scans, MRIs, and endoscopic ultrasound (EUS) to monitor pancreatic cysts, which helps in better risk assessment and diagnosis. EUS is particularly useful as it allows for high-resolution imaging and the ability to sample cyst fluid for analysis, which can help detect early signs of cancer.12789

How does the treatment for monitoring pancreatic cysts differ from other treatments?

This treatment uses advanced imaging techniques like CT scans, MRIs, and endoscopic ultrasound (EUS) to monitor pancreatic cysts, which is unique because it combines non-invasive and minimally invasive methods to provide detailed images and fluid analysis, helping to better assess the risk of malignancy compared to traditional methods.12789

What data supports the effectiveness of this treatment for monitoring pancreatic cysts?

Advanced imaging techniques like CT scans and MRIs, along with endoscopic ultrasound (EUS), are effective in evaluating pancreatic cysts by providing detailed images and allowing for fluid analysis, which helps in assessing the risk of malignancy.1271011

What data supports the effectiveness of the treatment for monitoring pancreatic cysts?

Advanced imaging techniques like CT scans and MRIs, along with endoscopic ultrasound (EUS), are effective in evaluating pancreatic cysts. These methods help in risk stratification and diagnosis, improving the detection and characterization of cysts, which is crucial for early intervention and management.1271011

Who Is on the Research Team?

DS

David S Weinberg

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for people aged 50-75 with pancreatic cysts larger than 1 cm, discovered in the last 6 months. It's not for those who are pregnant, have acute or chronic pancreatitis, a history of pancreatic cancer, specific low-risk lesions, family history of certain cancers, cyst features indicating surgery need, serious illnesses preventing surgery or current participation in other cyst monitoring.

Inclusion Criteria

I had a scan showing a pancreatic cyst larger than 1 cm within the last 6 months.
I am between 50 and 75 years old.
Patients of childbearing potential must not be known to be pregnant.

Exclusion Criteria

Patient must not be participating in any form of pancreatic cyst surveillance.
I do not have, nor have I ever had, pancreatitis.
I have never been diagnosed with pancreatic cancer.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging

Patients undergo MRI or CT at the beginning of the trial

1 week
1 visit (in-person)

Surveillance

Patients are monitored with MRI or CT based on cyst size and arm assignment

Up to 5 years
Multiple visits (in-person) based on surveillance schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Computed Tomography
  • Endoscopic Ultrasound
  • Magnetic Resonance Imaging
  • Quality-of-Life Assessment
  • Questionnaire Administration
Trial Overview The study compares two ways to monitor pancreatic cysts: more frequent vs less frequent check-ups using CT scans, MRIs and endoscopic ultrasounds. The goal is to find out which method leads to better patient outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm II (high intensity surveillance)Experimental Treatment5 Interventions
Group II: Arm I (low intensity surveillance)Experimental Treatment5 Interventions

Computed Tomography is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Computed Tomography for:
🇺🇸
Approved in United States as Computed Tomography for:
🇨🇦
Approved in Canada as Computed Tomography for:
🇯🇵
Approved in Japan as Computed Tomography for:
🇨🇳
Approved in China as Computed Tomography for:
🇨🇭
Approved in Switzerland as Computed Tomography for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials
122
Recruited
160,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Advanced imaging techniques like CT and MRI are essential for accurately assessing pancreatic cysts, especially as their detection increases due to more frequent abdominal imaging.
Endoscopic ultrasound (EUS) can provide critical information about pancreatic cysts, including the ability to analyze cyst fluid for markers like carcinoembryonic antigen (CEA), which helps identify high-risk mucinous cysts.
Intrapancreatic Accessory Spleen Masquerading as a Pancreatic Mucinous Neoplasm.Poola, S., Laks, S., Kragel, P., et al.[2020]
Transabdominal ultrasound with CT fusion (TAUS-f) demonstrated a high detection rate of 93% for pancreatic cystic lesions (PCLs) in a study of 33 patients, indicating its effectiveness as an imaging modality.
TAUS-f showed less variability in measuring smaller lesions (< 1.5 cm) compared to CT, suggesting it may provide more accurate assessments for certain PCLs and should be considered in patient surveillance protocols.
Real-Time Ultrasound-Computed Tomography Fusion with Volume Navigation to Assess Pancreatic Cystic Lesions.Mathew, M., Virarkar, M., Sun, J., et al.[2023]
Pancreatic cysts are quite common, found in 2% to 13% of abdominal imaging studies, and their management varies based on whether they are benign or have the potential for malignancy.
Diagnosis and risk assessment for malignant transformation of pancreatic cysts involve a combination of clinical history, imaging techniques like CT and MRI, and procedures such as endoscopic ultrasound and fine-needle aspiration of cyst fluid.
Analysis of Pancreatic Cyst Fluid.Ngamruengphong, S., Lennon, AM.[2018]

Citations

Intrapancreatic Accessory Spleen Masquerading as a Pancreatic Mucinous Neoplasm. [2020]
Real-Time Ultrasound-Computed Tomography Fusion with Volume Navigation to Assess Pancreatic Cystic Lesions. [2023]
Analysis of Pancreatic Cyst Fluid. [2018]
Accuracy of preoperative workup in a prospective series of surgically resected cystic pancreatic lesions. [2012]
Role of endoscopic ultrasound in the diagnosis of cystic lesions of the pancreas. [2016]
EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. [2022]
Clinically Acceptable Optimized Dose Reduction in Computed Tomographic Imaging of Necrotizing Pancreatitis Using a Noise Addition Software Tool. [2018]
Does successful EUS-guided pancreatic cyst chemoablation safely allow reduction in the frequency of radiographic surveillance? Long-term follow-up of randomized prospective data. [2023]
Endoscopic ultrasound of pancreatic tumors. [2017]
[The echographic characterization of pancreatic pseudocysts]. [2016]
11.United Statespubmed.ncbi.nlm.nih.gov
Pancreatic imaging: current and emerging technologies. [2016]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security