Monitoring Methods for Pancreatic Cyst

Not currently recruiting at 393 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the best way to monitor pancreatic cysts to determine which method leads to better patient outcomes. It compares two approaches: one with more frequent check-ups and another with fewer. The treatments use imaging techniques such as CT scans (Computed Tomography), MRIs (Magnetic Resonance Imaging), and endoscopic ultrasounds (Endoscopic Ultrasound). Suitable participants have pancreatic cysts larger than 1 cm and no history of pancreatitis or family history of pancreatic cancer. As an unphased trial, this study provides an opportunity to contribute to understanding the best monitoring methods for 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.

What prior data suggests that these monitoring methods are safe for patients with pancreatic cysts?

Research shows that the treatments used in this trial—CT scans, Endoscopic Ultrasound (EUS), and MRI—are generally safe for people.

CT scans involve a small amount of radiation, but studies indicate they are safe for monitoring pancreatic cysts when used properly. Researchers aim to identify which patients can be safely monitored with this method over time.

EUS, another imaging technique in this trial, uses a small ultrasound device to view the pancreas from inside the body. Studies show that EUS is effective and generally safe, though doctors must exercise caution as some procedure-related issues can occur, especially in certain patients.

MRI, the third method, uses magnets and radio waves to create images and does not involve radiation, making it a good option for long-term monitoring. Research supports that MRI is safe and ideal for regular check-ups of pancreatic cysts.

In summary, CT, EUS, and MRI are well-tolerated and have specific safety profiles. Their common use in medical practice supports their safety for monitoring pancreatic cysts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative surveillance strategies for monitoring pancreatic cysts, which can be precursors to cancer. Unlike traditional follow-up methods that may not tailor imaging frequency to cyst size and characteristics, this trial uses a personalized approach with two distinct surveillance intensities. The low-intensity arm involves periodic MRI or CT scans, while the high-intensity arm adjusts the frequency and type of imaging based on cyst size, incorporating endoscopic ultrasound (EUS) for more detailed assessment. This tailored monitoring could lead to earlier detection of changes, potentially improving outcomes by catching dangerous developments sooner.

What evidence suggests that these monitoring methods are effective for pancreatic cysts?

Research shows that CT scans, used in this trial, often detect pancreatic cysts by identifying tiny calcium deposits, which might indicate cancer. Studies have found that up to 70% of pancreatic cysts are discovered incidentally during CT scans. Endoscopic ultrasound (EUS), another method under study, provides a closer examination of these cysts. Some research suggests that EUS can lead to the complete disappearance of cysts in about 50% of patients within a year. MRI, also evaluated in this trial, excels at monitoring changes in cysts over time. It is non-invasive and helps predict the type of cyst and its potential risks. Each method offers unique strengths in monitoring pancreatic cysts, providing different ways to assess and manage the condition. ^{1 4 5 6 7}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299166/

Real-Life Management of Pancreatic Cysts: Simplified Review ... CT is indicated when there are calcifications within a cyst, thus raising suspicions of a malignant pancreatic cyst and concomitant pancreatic ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1521691825000800

Imaging assessment and Radiological features of ... The present review provides a comprehensive analysis of the current role and limitations of imaging in the evaluation and management of ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.222778

Pancreatic Cyst Surveillance: Who, Why, How? | Radiology This review describes the current surveillance and management guidelines and ongoing controversies for the commonly found pancreatic cystic lesions.

4. gastrojournal.org gastrojournal.org/article/S0016-5085(24)00248-8/fulltext

Diagnosis and Management of Pancreatic Cysts This review will summarize the current state of pancreatic cystic disease, focusing on the types of cysts, their diagnosis and treatment, and current ...

5. ai.jmir.org ai.jmir.org/2023/1/e40702/

Deep Learning to Detect Pancreatic Cystic Lesions ... - JMIR AI Studies have shown that up to 70% of PCLs are diagnosed incidentally on computed tomography (CT) scans due to unrelated symptoms, making CT ...

6. mdpi.com mdpi.com/2072-6694/16/24/4268

Advances for Managing Pancreatic Cystic Lesions This review highlights the challenges in diagnosing and managing PCLs and discusses the potential for artificial intelligence (AI) to improve accuracy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6103377/

Surveillance of Cystic Lesions of the Pancreas This review focuses on how to identify patients affected by PCN which could be safely sent to follow-up according to what is reported by both the guidelines ...