EUS-FNA With/Without MFB for Pancreatic Cysts

Recruiting at 3 trial locations

Overseen By Sandra Boimbo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Thrombocytopenia, Coagulopathy, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: Intraprocedural

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to diagnose pancreatic cysts, which are fluid-filled sacs in the pancreas. Researchers aim to determine if using a tiny tool called micro forceps, along with the standard fine needle aspiration (FNA), provides more accurate results in identifying potentially cancerous cysts. Participants will undergo either the usual FNA procedure alone (EUS-FNA Alone) or FNA combined with micro forceps biopsy (EUS-FNA plus MFB). This trial targets adults with pancreatic cysts larger than 20mm that are suitable for sampling, as determined by a doctor. The goal is to improve diagnostic methods, aiding doctors in choosing the best treatment paths. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance diagnostic accuracy for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that this method is safe for diagnosing pancreatic cysts?

Research shows that both EUS-FNA and EUS-FNA with MFB are generally safe for diagnosing pancreatic cysts.

For EUS-FNA alone, studies indicate it is usually well-tolerated. Pancreatitis, an inflammation of the pancreas, occurs rarely and mildly after the procedure. No deaths were reported in the studies, suggesting it is low-risk.

EUS-FNA with MFB, which includes an additional small tissue sample, also appears safe. A study with 101 patients found it was well-tolerated. A review of multiple studies supports this, showing the method is safe and effective for diagnosing these cysts.

Overall, both methods have a strong safety record, with low rates of serious complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring EUS-FNA with and without micro-forceps biopsy (MFB) for pancreatic cysts because it could enhance diagnostic precision. Unlike the standard EUS-FNA, which uses just a needle, the addition of micro-forceps allows for the collection of larger and more intact tissue samples, potentially leading to more accurate diagnoses. This could be a game-changer for patients, as a more precise diagnosis can lead to better treatment planning and potentially improved outcomes.

What evidence suggests that this trial's treatments could be effective for pancreatic cysts?

Research has shown that EUS-FNA, a procedure using a thin needle guided by ultrasound, effectively diagnoses pancreatic cysts. It is 91% accurate in identifying solid growths in the pancreas, though its accuracy can vary with cystic lesions. In this trial, one group of participants will receive EUS-FNA alone, while another group will receive EUS-FNA plus MFB. MFB, a technique using tiny forceps to take tissue samples from the cyst wall, seems to improve accuracy. Studies indicate that MFB can provide a better diagnosis by offering insights that fluid tests alone might miss. Together, these methods may help doctors better understand and treat pancreatic cysts. ^{4 6 7 8 9}

Who Is on the Research Team?

Anna Duloy, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults over 18 with pancreatic cysts larger than 20mm, suitable for needle aspiration based on symptoms, imaging, or patient concern. It's not for those with low platelets, bleeding risks, unsafe cyst characteristics via ultrasound, inability to consent, pregnancy or if surgery altered access to the cyst.

Inclusion Criteria

I am over 18 years old.

I have a cyst larger than 20 mm that my doctor thinks should be tested.

Exclusion Criteria

You are pregnant.

My medical tests show that draining my cyst could be unsafe.

My scans suggest I don't need a needle biopsy for my cyst.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EUS-guided fine needle aspiration with or without micro forceps biopsies for cyst characterization and sampling

Intraprocedural

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including recording adverse events

0-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EUS-FNA Alone
• EUS-FNA plus MFB

Trial Overview

The study compares two methods of examining pancreatic cysts: one using only Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA), and another combining EUS-FNA with Micro Forceps Biopsies (MFB) to improve diagnosis and inform treatment decisions.

How Is the Trial Designed?

Group I: 1). EUS-FNA plus MFB Active Control 1 Intervention

A 19-G needle plus micro-forceps will be used for FNA plus MFB.

Group II: 2). EUS-FNA Alone Active Control 1 Intervention

A 19-G needle will be used for FNA alone.

EUS-FNA Alone is already approved in European Union, United States for the following indications:

Approved in European Union as EUS-FNA for:

• Diagnosis of pancreatic cystic lesions
• Characterization of mucinous and non-mucinous cysts

Approved in United States as EUS-FNA for:

• Diagnosis of pancreatic cystic lesions
• Characterization of mucinous and non-mucinous cysts

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

US Endoscopy

Industry Sponsor

Trials

4

Recruited

1,900+

Published Research Related to This Trial

In a meta-analysis of 18 randomized controlled trials involving 2718 patients, endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) showed better diagnostic accuracy and adequacy for solid gastrointestinal lesions compared to fine-needle aspiration (EUS-FNA), requiring fewer needle passes to obtain sufficient tissue.

For solid pancreatic lesions, there was no significant difference in diagnostic accuracy or tissue quality between EUS-FNA and EUS-FNB, indicating that both methods are equally effective for this specific type of lesion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-Analysis Comparing Endoscopic Ultrasound-guided Fine-needle Aspiration With Endoscopic Ultrasound-guided Fine-needle Biopsy. Li, Z., Liu, W., Xu, X., et al.[2023]

Endoscopic ultrasound (EUS) guided fine-needle aspiration (FNA) is a safe and accurate method for diagnosing intrathoracic and intraabdominal conditions, but it carries a low risk of adverse events such as perforation, infections, and bleeding.

The review highlights specific risks associated with EUS FNA, including complications like pancreatitis and bile duct leaks, and offers strategies to minimize these risks during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic techniques in endoscopic ultrasound-guided fine needle aspiration for solid lesions: Adverse events and avoiding them. Fujii, LL., Levy, MJ.[2021]

In a study of 92 patients with small pancreatic cysts deemed benign on imaging, EUS-FNA successfully identified mucinous cysts in 41% of cases, aiding in patient management.

The cytologic examination showed a 99% negative predictive value for high-grade atypia, indicating that EUS-FNA is a reliable screening tool for determining the safety of conservative management of pancreatic cysts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) contributes to a triple-negative test in preoperative screening of pancreatic cysts. Wu, RI., Yoon, WJ., Brugge, WR., et al.[2016]

A nationwide survey of 101 medical professionals in Korea revealed that 79.2% routinely perform EUS-guided fine needle aspiration/biopsy for operable pancreatic solid masses, indicating its common use in clinical practice.

The study highlighted significant variability in techniques, such as needle types and sampling methods, suggesting a need for evidence-based guidelines to standardize practices and improve outcomes in EUS-FNA/FNB procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Practice Patterns of Endoscopic Ultrasound-Guided Tissue Sampling for Pancreatic Solid Mass in Korea: Outcomes of a National Survey. Ahn, DW., Chon, HK., Moon, SH., et al.[2023]

In a study of 85 EUS-guided fine-needle aspirations (FNA) performed on pancreatic cysts, the use of single-dose piperacillin/tazobactam effectively prevented any cases of cyst infection, fever, or sepsis, demonstrating its efficacy as prophylaxis.

The study showed that administering piperacillin/tazobactam intravenously at the time of the procedure is safe and convenient, with only one patient experiencing a mild adverse event (nausea), indicating a low risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of single-dose peri-procedural antibiotic prophylaxis for endoscopic ultrasound-guided fine-needle aspiration of pancreatic cystic lesions. Marinos, E., Lee, S., Jones, B., et al.[2018]

EUS-FNA is generally a safe procedure with serious adverse events occurring in only 0.29% of cases, but certain risk factors can increase the likelihood of complications.

Key risk factors for adverse events include undergoing endoscopic retrograde cholangiopancreatography (ERCP) on the same day, performing more than 15 to-and-fro movements during the procedure, and a higher number of punctures, which can lead to pancreatitis and infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors associated with adverse events during endoscopic ultrasound-guided tissue sampling. Lee, KH., Kim, EY., Cho, J., et al.[2018]

In a study of 332 fine needle aspirations (FNAs) from pancreatic masses, both FNAs and needle core biopsies demonstrated high sensitivity (89% for FNAs, 91% for core biopsies) and specificity (100% for both) in diagnosing pancreatic neoplasms.

Combining FNAs with needle core biopsies improved diagnostic yield, as it provided more cellular material for testing, leading to better detection of conditions like pancreatic adenocarcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of concurrent endoscopic ultrasound-guided fine needle aspirates and needle core biopsies in the diagnosis of pancreatic neoplasms. Selvaggi, SM.[2022]

In a study involving 67 patients, EUS-FNA combined with rapid on-site cytology demonstrated a high sensitivity of 94% and a specificity of 100% for diagnosing pancreatic cancer, making it a reliable method for early detection.

The use of rapid on-site cytology allowed for immediate evaluation of sample quality, which helped reduce the need for multiple sampling attempts, thus improving the efficiency of the diagnostic process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Utility of rapid on-site cytology in endoscopic ultrasonography-guided fine needle aspiration of pancreatic masses]. Furuhata, A., Shirahase, H., Shirai, T., et al.[2012]

In a study of 227 patients with pancreatic adenocarcinoma, both endoscopic ultrasound-guided fine needle aspiration (FNA) and fine needle biopsy (FNB) showed similar effectiveness in diagnosing malignancy, with rates of 69.4% for FNB and 65.5% for FNA.

The compatibility of cytology with histology was also comparable between the two methods, suggesting that FNB needles can be effectively used for cytological assessment in pancreatic lesions, just like FNA needles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The yield of cytology and histology obtained by endoscopic ultrasound-guided fine needle aspiration and biopsy needles in the diagnosis of pancreatic adenocarcinoma. Sbeit, W., Abu Hanna, N., Alejandro, L., et al.[2023]

EUS-guided core biopsy using two passes showed comparable diagnostic performance to the gold standard EUS-guided FNA with on-site cytopathology, with sensitivity rates of 91.7% for core biopsy versus 83% for FNA.

The study involved 26 patients and found that the core biopsy method was more time-efficient, suggesting it could be a viable alternative to the more time-consuming FNA approach for diagnosing gastrointestinal lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided fine-needle aspiration with on-site cytopathology versus core biopsy: a comparison of both techniques performed at the same endoscopic session. Lin, M., Hair, CD., Green, LK., et al.[2022]

In a study of 202 patients undergoing EUS-FNA and EUS-FNB for pancreatic masses, the use of FNB needles was associated with a higher rate of minor bleeding, particularly in cystic pancreatic tumors, where 8.2% experienced minor bleeding.

Major bleeding was rare, occurring in only 0.7% of cases with solid tumors, indicating that while EUS-FNB may increase minor bleeding risks, it remains a safe procedure overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The bleeding risk after endoscopic ultrasound-guided puncture of pancreatic masses. Razpotnik, M., Bota, S., Kutilek, M., et al.[2021]

The new Franseen tip fine needle biopsy (FNB) device demonstrated significantly higher histology scores and a diagnostic yield of 96% for solid lesions, compared to 88% for the traditional fine needle aspiration (FNA) technique, based on a study involving 51 FNB and 50 FNA samples.

The FNB technique required fewer needle passes to achieve these results, indicating improved efficiency, although two patients experienced abdominal pain post-procedure, highlighting a need for monitoring safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Assessment of the Performance of a New Fine Needle Biopsy Device for EUS-Guided Sampling of Solid Lesions. El Hajj, II., Wu, H., Reuss, S., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4784176/

Endoscopic Ultrasound-Guided Fine-Needle Aspiration of ...

The results obtained were found to be superior to those of standard EUS-guided FNA. In his study comparing EUS-FNB alone with EUS-FNA with ROSE followed by EUS- ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1424390312005479

Endoscopic ultrasound guided fine needle aspiration for ...

For example, a recent meta-analysis of the diagnostic accuracy of EUS-FNA for solid pancreatic neoplasms has demonstrated a sensitivity and specificity of 91% ...

3.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.961293/full

The clinical impact of endoscopic ultrasound-guided fine ...

EUS-FNA was clinically significant in about 40% of low-risk PCLs, especially in young, large cyst size, and overweight patients.

4.

bmjopengastro.bmj.com

bmjopengastro.bmj.com/content/12/1/e001893

Endoscopic ultrasound for pancreatic cystic lesions

This review aims to outline the key aspects of EUS in the evaluation of PCLs, covering a range of modalities from morphological assessment and ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4202358/

Endoscopic ultrasound guided fine needle aspiration and ...

EUS-FNA remains a minimally invasive, easy to perform, and altogether more effective method of sampling tissue from deep-seated lesions than any other ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38976379/

Risk of Pancreatitis After Endoscopic Ultrasound-Guided ...

We note with high certainty that pancreatitis after EUS-FNA of PCLs is infrequent and mild in severity with no mortality in the included cohort.

7.

cghjournal.org

cghjournal.org/article/S1542-3565(04)00618-4/fulltext

EUS-guided fine needle aspiration of pancreatic cysts

Endoscopic ultrasound-guided fine-needle aspiration (EUS FNA) of pancreatic cysts is considered safe, however, data are conflicting regarding complication rates ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1542356504006184

EUS-guided fine needle aspiration of pancreatic cysts

The aim of this study was to determine the complication rate of EUS-guided pancreatic cyst aspiration and predictors of these complications. Methods: Results of ...

9.

journals.lww.com

journals.lww.com/ajg/fulltext/2011/10002/diagnostic_yield_and_safety_of_endoscopic.163.aspx

Diagnostic Yield and Safety of Endoscopic Ultrasound ...

Outcomes recorded included number of FNA passes, histologic findings, fluid CEA and amylase, immediate complications, 30-day hospital admission rate, 30-day ...