Biopsy Methods for Pancreatic Lesions

Overseen By Michael Ladna, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Hematologic disorders, Acute pancreatitis, Cardiorespiratory dysfunction, Previous chemotherapy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of taking tissue samples from pancreatic lesions to determine which yields better results. One method uses a standard needle, while the other employs a new motorized device (Endoscopic Ultrasound Guided Biopsy with Core Needle Biopsy Device). The goal is to identify which method provides higher quality samples, less blood contamination, and requires less time. Individuals needing a biopsy for a pancreatic lesion larger than 2.5 cm and able to give consent might be suitable candidates. As an unphased trial, this study allows participants to contribute to improving biopsy techniques 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 these biopsy methods are safe for pancreatic lesions?

Research has shown that an endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is generally safe, even in challenging cases like pancreatic areas with many blood vessels. One study found the chance of unwanted effects from EUS-FNB was low, about 2.3%, similar to other biopsy methods, indicating it is well-tolerated.

The new device, EUS-CNB, is being tested against EUS-FNB to determine if it can obtain better tissue samples with just one needle insertion. Although specific safety data for EUS-CNB is not yet available, the similar techniques suggest it could be equally safe. Overall, both methods aim to safely obtain the best tissue sample possible for diagnosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new biopsy method for pancreatic lesions that could offer significant improvements over the current standard. The novel EUS-CNB device is different from the standard EUS-FNB technique because it utilizes a unique core needle biopsy approach, potentially providing more accurate tissue samples. This improvement in sample quality could lead to better diagnostic precision, enabling more tailored and effective patient treatments. By enhancing the accuracy of pancreatic lesion diagnosis, this method might significantly impact patient outcomes and treatment strategies.

What evidence suggests that these biopsy methods are effective for pancreatic lesions?

In this trial, participants will undergo one of two biopsy methods for pancreatic lesions. Studies have shown that endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) effectively diagnoses pancreatic issues. This method is the primary way doctors collect tissue samples for diagnosis. Research indicates that EUS-FNB is both safe and effective. Meanwhile, the trial will also evaluate a new tool, the motorized core needle biopsy device (EUS-CNB), which aims to improve the process by obtaining better tissue samples with fewer needle insertions. Early results suggest that EUS-CNB might provide clearer samples with less blood, aiding doctors in making accurate diagnoses. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who need a biopsy of pancreatic solid lesions larger than 2.5 cm and can give consent. It's not suitable for pregnant women, those with cardiorespiratory issues preventing sedation, prior chemo or radiotherapy for pancreatic cancer, severe blood disorders, or recent acute pancreatitis.

Inclusion Criteria

Patients who can give consent

I need a procedure to sample tissue from a pancreatic lesion larger than 2.5 cm.

Exclusion Criteria

Pregnant females

I cannot be sedated due to heart or lung problems.

I have had chemotherapy or radiotherapy for pancreatic cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo EUS-guided biopsy using either the 22-gauge FNB needle or the novel EUS-CNB device

Single day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and safety 1-2 months after the procedure

1-2 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Ultrasound Guided Biopsy with Core Needle Biopsy Device

Trial Overview The study compares the quality and accuracy of tissue samples from pancreatic lesions using two methods: a single puncture with a regular needle (22 G FNB) versus a motorized core needle biopsy device (EUS CNB). It also looks at blood contamination rates and procedure duration.

How Is the Trial Designed?

Group I: EUS-CNB Experimental Treatment 1 Intervention

This arm will undergo biopsy with the novel EUS-CNB device

Group II: EUS-FNB Active Control 1 Intervention

This arm will undergo biopsy via the standard of care, which involves EUS-guided biopsy using the 22-gauge FNB needles

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. giejournal.org giejournal.org/article/S0016-5107(25)01378-1/fulltext

EUS-guided fine-needle biopsy sampling of solid ... EUS-guided fine-needle biopsy sampling (EUS-FNB) of solid pancreatic mass lesions has become the mainstay for acquiring tissue for diagnosis and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499387222001497

Original Article/Pancreas Percutaneous ultrasound and ... In conclusion, both percutaneous US- and EUS-guided biopsies of solid pancreatic lesions are safe and effective; though the diagnostic accuracy of EUS-FNA is ...

3. nature.com nature.com/articles/srep22978

Endoscopic ultrasound-guided fine needle core biopsy for ... Endoscopic ultrasound-guided fine needle core biopsy (EUS-FNB) has been used as an effective method of diagnosing pancreatic malignant lesions.

4. mdpi.com mdpi.com/2077-0383/13/11/3108

A Systematic Review and Meta-Analysis of Diagnostic ... This meta-analysis aims to compare the diagnostic performance of two minimally invasive biopsy approaches for pancreatic tissue sampling.

5. wjgnet.com wjgnet.com/1007-9327/full/v27/i26/4194.htm

Endoscopic ultrasound fine needle aspiration vs ... Here we review prospective comparative data on EUS-FNA vs EUS-FNB for pancreatic masses, subepithelial lesions, and lymph node biopsy (Table 1-3) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10606996/

Safety and Diagnostic Yield of Endoscopic Ultrasound ... Therefore, EUS-FNB may be safe with a high diagnostic yield, even for hypervascular solid pancreatic lesions. Keywords: endoscopic ultra-sound ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07240818

Comparison of FNB to EUS-CNB for Pancreatic Lesions The primary aim of this study is to compare the tissue specimen quality and diagnostic accuracy of biopsies obtained with one puncture of a ...

8. e-ce.org e-ce.org/journal/view.php?doi=10.5946/ce.2020.101

Endoscopic Ultrasound-Guided Fine Needle Biopsy ... There was no difference in adverse event rate between FNA and FNB needles (1.8% and 2.3% respectively, p=0.64). Conclusions: FNB provides superior diagnostic ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508521030948

Endoscopic Ultrasound–guided Fine-needle Biopsy With ... This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB ...