Monitoring Methods for Pancreatic Cyst

Recruiting at 382 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ECOG-ACRIN Cancer Research Group

Disqualifiers: Acute pancreatitis, Chronic pancreatitis, Pancreatic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

4606 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 7 8 9}

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. ^{1 2 7 8 9}

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. ^{1 2 7 10 11}

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. ^{1 2 7 10 11}

Who Is on the Research Team?

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.

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?

Group I: Arm II (high intensity surveillance) Experimental Treatment 5 Interventions

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.

Group II: Arm I (low intensity surveillance) Experimental Treatment 5 Interventions

Patients undergo MRI or 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 EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years.

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:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, and neurological disorders

Approved in United States as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Approved in Canada as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Approved in Japan as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Approved in China as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

Approved in Switzerland as Computed Tomography for:

• Diagnostic imaging for various conditions including cancer, cardiovascular diseases, neurological disorders, and others

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Pancreatic Cyst Fluid. Ngamruengphong, S., Lennon, AM.[2018]

In a study of 32 patients with pancreatic cysts, MRI demonstrated higher sensitivity (91%) than EUS (78%) for diagnosing mucinous cysts, indicating MRI may be more effective for this specific diagnosis.

Both MRI and EUS are comparable in characterizing pancreatic cysts, but their combined use improves diagnostic sensitivity, while EUS-FNA showed low sensitivity for diagnosing mucinous cysts despite high specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of preoperative workup in a prospective series of surgically resected cystic pancreatic lesions. de Jong, K., van Hooft, JE., Nio, CY., et al.[2012]

Endoscopic ultrasound (EUS) is highly effective for detecting and characterizing pancreatic cystic lesions, providing high-resolution imaging and enabling guided needle aspiration for diagnosis.

Cyst fluid tumor markers, particularly CEA, significantly enhance the sensitivity for detecting malignancy in pancreatic cysts, with distinct CEA levels indicating different types of cystic tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of endoscopic ultrasound in the diagnosis of cystic lesions of the pancreas. Brugge, WR.[2016]

EUS-guided fine-needle aspiration (FNA) of pancreatic cysts has a low complication rate of 2.2%, with complications including pancreatitis and abdominal pain, but no specific patient or cyst characteristics were found to predict these complications.

The study reviewed data from 603 patients over a period from March 1996 to October 2003, indicating that EUS FNA is a safe procedure for pancreatic cysts, with complication rates comparable to those for solid pancreatic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. Lee, LS., Saltzman, JR., Bounds, BC., et al.[2022]

A study involving 84 patients with necrotizing pancreatitis demonstrated that increasing image noise in contrast-enhanced CT scans can significantly reduce radiation doses by up to 84% without compromising diagnostic acceptability.

Observers were able to maintain confidence in identifying anatomical structures and complications of necrotizing pancreatitis even with increased noise levels, suggesting that higher noise levels can be safely tolerated in imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Acceptable Optimized Dose Reduction in Computed Tomographic Imaging of Necrotizing Pancreatitis Using a Noise Addition Software Tool. Jaffe, TA., Tian, X., Bashir, MR., et al.[2018]

In a study of 52 patients who underwent endoscopic ultrasound-guided pancreatic cyst chemoablation, 69.2% achieved complete response and all patients could safely reduce their radiographic surveillance to annual or less without recurrence or malignancy.

The ChARM Post-treatment Reduced Radiographic Surveillance Protocol significantly lowered healthcare costs to $7200 compared to $19,437.44 and $12,526.52 under the Fukuoka and ACG guidelines, respectively, while most patients preferred this reduced surveillance approach due to lower logistical and emotional burdens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does successful EUS-guided pancreatic cyst chemoablation safely allow reduction in the frequency of radiographic surveillance? Long-term follow-up of randomized prospective data. Moyer, MT., Heinle, JW., Rhoades, SE., et al.[2023]

ECT and CT scans are highly effective diagnostic tools for pancreatic pseudocysts, achieving correct evaluations in 95% of cases.

ECT scans provide real-time data and detailed information about the cyst walls, aiding in both diagnosis and determining the best treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The echographic characterization of pancreatic pseudocysts]. Vietri, F., Annessi, M., Fabbri, F., et al.[2016]

Multidetector row spiral computed tomography is more effective than single-detector CT for detecting and staging pancreatic adenocarcinoma, making it a crucial tool in pancreatic cancer diagnosis.

Endoscopic ultrasound with fine needle aspiration is the most accurate method for diagnosing and staging nonmetastatic pancreatic cancer, particularly in assessing whether tumors can be surgically removed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatic imaging: current and emerging technologies. Nichols, MT., Russ, PD., Chen, YK.[2016]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Intrapancreatic Accessory Spleen Masquerading as a Pancreatic Mucinous Neoplasm. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Time Ultrasound-Computed Tomography Fusion with Volume Navigation to Assess Pancreatic Cystic Lesions. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Analysis of Pancreatic Cyst Fluid. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Accuracy of preoperative workup in a prospective series of surgically resected cystic pancreatic lesions. [2012]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Role of endoscopic ultrasound in the diagnosis of cystic lesions of the pancreas. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

EUS-guided fine needle aspiration of pancreatic cysts: a retrospective analysis of complications and their predictors. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Clinically Acceptable Optimized Dose Reduction in Computed Tomographic Imaging of Necrotizing Pancreatitis Using a Noise Addition Software Tool. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

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]

9. France pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound of pancreatic tumors. [2017]

10. Italy pubmed.ncbi.nlm.nih.gov

[The echographic characterization of pancreatic pseudocysts]. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Pancreatic imaging: current and emerging technologies. [2016]