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A Randomized Controlled Trial Of Endoscopic Ultrasound-Guided Fine-Needle Aspiration With And Without A Stylet : A Pilot Study


N/A
18 Years
85 Years
Open (Enrolling)
Both
Mediastinal or Intra-abdominal Lymphadenopathy,, Pancreatic Masses,, Left Adrenal Masses,, Gastrointestinal Submucosal Lesions, and, Liver Masses

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Trial Information

A Randomized Controlled Trial Of Endoscopic Ultrasound-Guided Fine-Needle Aspiration With And Without A Stylet : A Pilot Study


Various techniques have been described to optimize accuracy, efficiency, and quality of
EUS-FNA specimens. FNA is typically performed using a 22- or 25-gauge needle with a stylet
under EUS guidance. The lesion is punctured with a stylet in place or slightly withdrawing
the needle. After puncture, the stylet is pushed out of the needle tip and then the needle
is moved to and fro within the lesion and this process is repeated for each needle pass. It
is currently believed that the use of a stylet for EUS-FNA helps prevent clogging of the
needle by gut wall tissue, which could limit the ability to aspirate cells from the target
lesion. This may improve the quality of specimens and hence enhance the diagnostic yield of
specimens obtained. This is a logical assumption, but there are no data demonstrating
clearly that the use of a stylet increases the yield of EUS-FNA. At the present time, it is
recommended that the stylet is re-inserted back into the needle prior to each FNA pass. The
use of a stylet during EUS-FNA is cumbersome, time and energy consuming and increases the
costs of EUS-FNA needle systems. In some circumstances, the stylet may actually make EUS-FNA
very difficult as it may be impossible to advance or remove the stylet once the target has
been punctured. This tends to occur when the echoendoscope or the needle is bent and a large
(19 gauge) needle is being used. In addition, the data comparing the effectiveness of
EUS-FNA with stylet to FNA without stylet is limited. Paquin et al compared the adequacy,
the bloodiness, and the yield of FNA samples obtained with a stylet to FNA without a stylet.
In this study, the use of stylet for EUS-FNA was associated with a reduced specimen adequacy
and more bloody passes. 13 Thus the use of a stylet for EUS-FNA is questionable and needs
further investigation. If the diagnostic yield, adequacy and quality of specimens obtained
by EUS-FNA without a stylet is found to be equivalent to that with a stylet, this could
potentially make a strong case for not using a stylet and thus making the procedure easier,
more time- and cost-efficient. The hypothesis and specific aims of this prospective
randomized controlled trial are as follows:

First hypothesis: There is no difference in the degree of cellularity, contamination, and
amount of blood in samples obtained by EUS-FNA with and without a stylet Specific Aim #1: To
compare the degree of cellularity, contamination, and amount of blood in samples obtained by
EUS-FNA with and without a stylet

Second hypothesis: There is no difference in the diagnostic yield of malignancy in specimens
obtained by EUS-FNA with a stylet compared with EUS-FNA without a stylet.

Specific Aim #2: To compare the diagnostic yield of malignancy in specimens obtained by
EUS-FNA with and without a stylet.

Third hypothesis: An acceptable level of inter-observer agreement exists among
cytopathologists in the assessment of specimens obtained from EUS-FNA with stylet and
EUS-FNA without a stylet.

Specific Aim #3: To assess the inter-observer agreement among cytopathologists in the
evaluation of specimens obtained from EUS-FNA with stylet and specimens obtained from
EUS-FNA without a stylet.


Inclusion Criteria:



- Age greater than 18 years

- Presence of mediastinal or intra-abdominal lymphadenopathy, solid pancreatic mass,
left adrenal mass, gastrointestinal submucosal lesions or liver mass confirmed by at
least a single investigational modality - CT scan, magnetic resonance imaging,
endoscopy.

- Capable of providing informed consent

Exclusion Criteria:

- Severe coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000)

- Lesion unable to be sampled due to the presence of intervening blood vessels

- Results of EUS-FNA would not impact patient management

- Inability to provide informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet

Outcome Description:

First hypothesis: There is no difference in the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet Specific Aim #1: To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Amit Rastogi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kansas City Veterans Affairs Medical Center

Authority:

United States: Federal Government

Study ID:

AR0007

NCT ID:

NCT01213290

Start Date:

September 2009

Completion Date:

March 2010

Related Keywords:

  • Mediastinal or Intra-abdominal Lymphadenopathy,
  • Pancreatic Masses,
  • Left Adrenal Masses,
  • Gastrointestinal Submucosal Lesions, and
  • Liver Masses
  • Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)
  • Stylet
  • Marfan Syndrome
  • Lymphatic Diseases

Name

Location

Kansas City VA Medical CenterKansas City, Missouri  64128
Veterans Affairs Medical CenterKansas City, Missouri  64128