Prospective Paired Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
18 Years
90 Years
Both
Pancreatic Tumor
Trial Information
Prospective Paired Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Diagnostic Yield
Outcome Time Frame:
One-week post procedure
Safety Issue:
No
Principal Investigator
Vanessa Shami, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Virginia
Authority:
United States: Institutional Review Board
Study ID:
15779
NCT ID:
NCT01673334
Start Date:
September 2011
Completion Date:
Related Keywords:
- Pancreatic Tumor
- Pancreas Tumor EUS FNA Core Biopsy Procore FNB
- Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| University of Virginia | Charlottesville, Virginia 22908 |
