Trial Information

Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA of Solid Lesions. A Randomized, Prospective, Blinded, and Controlled Trial

Endoscopic ultrasound (EUS) has become the modality of choice for imaging the
gastrointestinal wall and surrounding structures. EUS is not only used for diagnostic
purposes but is also useful in tissue acquisition by fine needle aspiration (FNA) thus
helping in diagnosis and treatment of various lesions. EUS-FNA is being routinely used to
sample various cystic and solid lesion involving the pancreas, liver, gastric wall, adrenal
glands, kidney as well as lymph nodes in areas adjacent to the gastrointestinal tract.

EUS-FNA is performed by passing a needle through a working channel located within the
echoendoscope. The needle passes out of the endoscope in the same plane as the ultrasound
sensor, allowing the operator to visualize the path of the needle. This allows directed
needle puncture of the lesion and avoidance of other structures such as blood vessels. After
the needle is passed into the lesion of interest, varying degrees of suction is applied to
obtain an aspirate. The needle is withdrawn from the scope channel and aspirate is pushed
out of the needle either with a stylet or by using a syringe to pump air to flush out the
aspirate for further cyto-pathological evaluation. The cells obtained at needle aspiration
can help in differentiating benign from malignant, and also tell the origin of the tumor if
malignant.

One of the advantages of EUS-FNA is that the sample can be quickly stained and processed in
the procedure room and a diagnosis can be given to the endosonographer during the procedure.
The cyto pathologist if unable to provide an accurate diagnosis on the site is at least able
to assess the adequacy of cellularity. This optimal and in some centers 5-6 needle passes
are routinely made and the cells sent to the cytopathological laboratory for further
examination, preparation of cell block etc.,. The ability to make an accurate diagnosis, ,
is dependent on the quality of the sample obtained. Not all the centers have the capability
of having an on site cytopathologist to assess the cellularity and or make a diagnosis at
the bedside. Moreover if the cellularity is inadequate or if the diagnosis is uncertain, the
patient has to undergo a repeat procedure resulting in increased costs, risks and also the
agony of waiting for a diagnosis.

ROLE OF SUCTION IN EUS-FNA It was believed that applying suction to the needle while it is
within the desired lesion, improves the quality of aspirate. However, recently there has
been a trend to use less or no suction as that provides a "less bloody" specimen. The only
randomized trial comparing suction to non suction techniques observed a higher sensitivity
and negative predictive values for malignancy in the suction group compared with the
non-suction group. In addition, bloodiness or contamination was not increased in the suction
group.

Current suction technique involves suctioning the aspirate into the needle that has an air
column. The needle is not flushed with any liquid prior to passing into the desired solid
lesion. Suction is applied when the needle is within the lesion leading to aspiration of
tissue into the needle. This is the standard technique and some have done with and without
the stylet. There are some data that favor non use of a stylet.

WET SCTION TECHNIQUE:

Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the
column of air with saline. The needle is now passed into the desired lesion. Suction is
applied at maximal strength and needle moved back and forth within the lesion to obtain as
aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves
into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a
stylet and or flushing air into the needle with a syringe HYPOTHESIS The effect of suction
for the purpose of aspirating cells and / or tissue during fine needle biopsy may be
significantly improved by filling the column of the needle with a less compressible fluid.
The volume of vacuum being pulled may be negatively impacted by the expansion of air within
the needle. Replacing the air with sterile saline may thus improve the suction transferred
to the needle tip by ensuring that the full volume of the vacuum syringe is transferred to
the distal tip of the needle. This effect would be most pronounced in larger gauge needles
which would have a larger internal volume. An additional benefit of filling the needle with
saline prior to aspiration is the speed of the pressure transfer. The theory is that the air
in the needle may absorb some of the force of the sudden application of vacuum. A column of
saline in the needle may increase the velocity of the pressure transfer providing more
tissue and less blood.