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Tissue Sampling

EUS-Guided Biopsy vs Aspiration for Pancreatic Cancer

Phase 4
Waitlist Available
Led By Vanessa Shami, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient is scheduled for diagnostic endosonography by their referring provider or UVa gastroenterologist
Age greater than 18 and less than 90 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-week post procedure
Awards & highlights

Study Summary

This trial is testing if a less invasive method of testing for pancreatic tumors is just as effective as the current standard method.

Who is the study for?
This trial is for English-speaking adults aged 18-90 with a solid pancreatic mass lesion, who have not yet had a tissue diagnosis. They must be scheduled for diagnostic endosonography and cannot have uncorrectable blood clotting issues. Pregnant individuals or those unable to understand the consent form are excluded.Check my eligibility
What is being tested?
The study compares two methods of obtaining tissue samples from the pancreas: Fine Needle Aspiration (FNA) and Core biopsy (FNB). It aims to determine which method has better diagnostic yield, ease of use, and technical success in evaluating pancreatic tumors.See study design
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, minor bleeding, bruising or infection. Rarely more serious complications like significant bleeding or injury to surrounding organs could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for an endosonography.
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I am between 18 and 90 years old.
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I have a solid mass in my pancreas seen on scans, without a biopsy done yet.
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My blood clotting tests are normal or can be corrected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-week post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and one-week post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic Yield

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fine Needle Aspiration and Core BiospsyExperimental Treatment1 Intervention
Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fine Needle Aspiration (FNA) and Core biopsy (FNB)
2011
Completed Phase 4
~40

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
748 Previous Clinical Trials
1,235,963 Total Patients Enrolled
Vanessa Shami, MDPrincipal InvestigatorUniversity of Virginia

Media Library

Core biopsy (FNB) (Tissue Sampling) Clinical Trial Eligibility Overview. Trial Name: NCT01673334 — Phase 4
Pancreatic Tumors Research Study Groups: Fine Needle Aspiration and Core Biospsy
Pancreatic Tumors Clinical Trial 2023: Core biopsy (FNB) Highlights & Side Effects. Trial Name: NCT01673334 — Phase 4
Core biopsy (FNB) (Tissue Sampling) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01673334 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Fine Needle Aspiration (FNA) and Core biopsy (FNB)?

"Our team rated the safety of Fine Needle Aspiration (FNA) and Core biopsy (FNB) to be a 3, as this treatment is already approved for use in Phase 4 trials."

Answered by AI

Is this research program still open to taking on new participants?

"By referencing the clinicaltrials.gov data, it is apparent that this trial has been inactive since 2012; however, there are a plethora of other studies currently recruiting patients at present."

Answered by AI

Who has the opportunity to participate in this clinical investigation?

"This clinical trial is enrolling 40 participants with cancer, ranging from 18 to 90 years of age. To qualify for this study, applicants must have a solid lesion within the pancreas on imaging scans and normal coagulation levels that can be corrected by fresh frozen plasma. Moreover, they must demonstrate English fluency and comprehension as well as having signed an informed consent form before scheduling diagnostic endosonography."

Answered by AI

Are adults aged 18 and above admissible for this investigation?

"As per the provided guidelines, this research requires patients to be between 18 and 90 years of age. Additionally, there are 308 trials specifically for minors while 2707 clinical studies are tailored towards individuals over 65."

Answered by AI
~3 spots leftby Mar 2025