Pancreatic TumorPhase 4NCT01673334
Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
A Phase 4 study testing Fine Needle Aspiration (FNA) and Core biopsy (FNB) in people with Pancreatic Tumor, run by University of Virginia at 1 site in United States.
Trial summary
We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield than core biopsy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Tumor
- What is being tested?
- Fine Needle Aspiration (FNA) and Core biopsy (FNB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to 9 Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 and less than 90 years.
- Presence of a solid (greater than 60%) mass lesion within the pancreas on cross-sectional imaging, without a preceding tissue diagnosis.
- Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not correct with the administration of fresh frozen plasma.
- The patient must read and speak english and has signed informed consent document.
- The patient is scheduled for diagnostic endosonography by their referring provider or UVa gastroenterologist.
Who cannot join
- Age less than 18 or greater than 90 years.
- The patient is unable to read or understand the consent form.
- The patient is currently pregnant.
- The patient has an uncorrectable coagulopathy as defined by a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) which does not improve with administration of fresh frozen plasma.
- The patient has a pancreatic mass lesion which is predominantly cystic (greater than 40%).
- No mass lesion is identified at the time of endosonography.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Prospective Paired Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield than core biopsy.
Read the detailed description
Background: Endoscopic ultrasonography (EUS) has been utilized for over a decade to evaluate endo-luminal and adjacent tumors of the gastrointestinal tract. In that time, EUS guided fine needle aspiration (FNA) has emerged as the dominant means of tissue acquisition for pancreatic mass lesions. FNA has several limitations, foremost of which is the absence of a clear relationship between cellular elements and stroma which may be required for accurate diagnosis. Additionally, EUS-FNA requires the assistance of an on-site cytopathologist for optimal yield which limits its dissemination and increases its cost. A novel EUS histology needle (EUS-FNB) is available in the 22 gauge diameter which may allow for more accurate diagnosis without the need for on site cytopathology assistance. Aim: To prospectively compare the diagnostic yield, number of needle passes, and ease of use of 22 gauge EUS-FNA and EUS-FNB. Hypothesis: EUS-FNB is superior to traditional EUS-FNA with regard to all primary and secondary outcome measures. Methods: Patients scheduled for EUS evaluation of solid pancreatic tumors will be screened for enrollment at either a preceding clinical encounter or the morning of their scheduled procedure. English-speaking patients between the ages of 18 and 90 with a predominantly solid (greater than 60%) mass lesion of the pancreas will be considered for enrollment. Exclusion criteria include pregnancy, a predominantly cystic lesion, and the presence of an uncorrectable coagulopathy. Patients will then undergo both EUS-FNA and EUS-FNB for the collection of tissue specimens required for clinical care. The results of the experimental approach (EUS-FNB) will be compared to the control approach (EUS-FNA). Data collected for each procedure will include: instrument use order, number of needle passes with each device, technical success of each device, complications, ease of use, and the ultimate pathological diagnosis / diagnostic yield for each device. Each data category will then be compared utilizing standard statistical tests including chi-squared, Fishers' exact, or student's t test.
- Conditions
- Pancreatic Tumor
- Being tested
- Fine Needle Aspiration (FNA) and Core biopsy (FNB)
- Keywords
- Pancreas Tumor EUS FNA Core Biopsy Procore FNB
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine Needle Aspiration (FNA) and Core biopsy (FNB)Device
| Study group | Role | What they receive |
|---|---|---|
| Fine Needle Aspiration and Core Biospsy | Experimental | Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor. Receives: Device: Fine Needle Aspiration (FNA) and Core biopsy (FNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield
Measured: One-week post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startSep 2011
- Primary completion9 Jul 2013
- Study completion9 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic TumorStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Shami, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673334
- Sponsor's protocol ID
- 15779
- Status last verified
- Feb 2024
- First submitted
- 22 Aug 2012
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Paired Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
- ClinicalTrials.gov ID
- NCT01673334
- Acronym / sponsor ID
- 15779
- Conditions
- Pancreatic Tumor
- Keywords
- Pancreas Tumor EUS FNA Core Biopsy Procore FNB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 9 Jul 2013 (actual)
- Study completion
- 9 Jul 2013 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield than core biopsy.
Detailed description
Background: Endoscopic ultrasonography (EUS) has been utilized for over a decade to evaluate endo-luminal and adjacent tumors of the gastrointestinal tract. In that time, EUS guided fine needle aspiration (FNA) has emerged as the dominant means of tissue acquisition for pancreatic mass lesions. FNA has several limitations, foremost of which is the absence of a clear relationship between cellular elements and stroma which may be required for accurate diagnosis. Additionally, EUS-FNA requires the assistance of an on-site cytopathologist for optimal yield which limits its dissemination and increases its cost. A novel EUS histology needle (EUS-FNB) is available in the 22 gauge diameter which may allow for more accurate diagnosis without the need for on site cytopathology assistance. Aim: To prospectively compare the diagnostic yield, number of needle passes, and ease of use of 22 gauge EUS-FNA and EUS-FNB. Hypothesis: EUS-FNB is superior to traditional EUS-FNA with regard to all primary and secondary outcome measures. Methods: Patients scheduled for EUS evaluation of solid pancreatic tumors will be screened for enrollment at either a preceding clinical encounter or the morning of their scheduled procedure. English-speaking patients between the ages of 18 and 90 with a predominantly solid (greater than 60%) mass lesion of the pancreas will be considered for enrollment. Exclusion criteria include pregnancy, a predominantly cystic lesion, and the presence of an uncorrectable coagulopathy. Patients will then undergo both EUS-FNA and EUS-FNB for the collection of tissue specimens required for clinical care. The results of the experimental approach (EUS-FNB) will be compared to the control approach (EUS-FNA). Data collected for each procedure will include: instrument use order, number of needle passes with each device, technical success of each device, complications, ease of use, and the ultimate pathological diagnosis / diagnostic yield for each device. Each data category will then be compared utilizing standard statistical tests including chi-squared, Fishers' exact, or student's t test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fine Needle Aspiration and Core Biospsy | Experimental | Device: Fine Needle Aspiration (FNA) and Core biopsy (FNB)Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 18 and less than 90 years.
- Presence of a solid (greater than 60%) mass lesion within the pancreas on cross-sectional imaging, without a preceding tissue diagnosis.
- Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not correct with the administration of fresh frozen plasma.
- The patient must read and speak english and has signed informed consent document.
- The patient is scheduled for diagnostic endosonography by their referring provider or UVa gastroenterologist.
Key exclusion criteria (6 listed)
- Age less than 18 or greater than 90 years.
- The patient is unable to read or understand the consent form.
- The patient is currently pregnant.
- The patient has an uncorrectable coagulopathy as defined by a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) which does not improve with administration of fresh frozen plasma.
- The patient has a pancreatic mass lesion which is predominantly cystic (greater than 40%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fine Needle Aspiration (FNA) and Core biopsy (FNB) | Device | Fine Needle Aspiration and Core Biospsy |
Primary outcome
Diagnostic Yield
Time frame: One-week post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Shami, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fine Needle Aspiration (FNA) and Core biopsy (FNB) in people with Pancreatic Tumor, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield (time frame: One-week post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.