Trial Information

Prospective Study Comparing Methods of Obtainment of Specimen After EUS-FNA in Patients With Peri-pancreatic Mass

On-site cytopathology interpretation during EUS-FNA has a significant clinical impact by
increasing the diagnostic yield of the FNA. However, many hospitals do not have provision
for on- site diagnosis of EUS FNA specimen. Therefore, optimal specimen obtainment and
preparation of EUS FNA are is important to accurate diagnosis. EUS FNA is performed with or
without self-retracting 10-mL syringe according to endosonographer's preference. In general,
if there is too little cellularity on immediate cytologic evaluation, then use more suction,
and, conversely, if the samples are too bloody, then use less suction. However, it is hard
to determine the quality of specimen without on-site cytopathology interpretation. The
actual way material is expressed from the needle may influence yield. Injecting air to
express the material is problematic, because the material may spray out uncontrollably, risk
of air artifact and specimen clotting may increase . A more controlled method is to pushing
the stylet and slowly advance it to the needle tip. But use of the stylet during EUS-FNA is
not only difficult and time consuming process but also increasing the risk of accidental
needle stick injury. However, there is no firm evidence which one is the appropriate,
suction or no suction and pushing the stylet or injecting air. If there was no significant
difference between each methods, appropriate methods of obtaining and preparing aspirates
undergoing EUS-FNA is no suction and injecting air and EUS FNA may perform more easier and
shorter.

In this prospective randomized controlled trial, patients with peripancreatic mass for
EUS-FNA will be included. One patient will be underwent at least four puncture during
EUS-FNA. The sequence of EUS-FNA with first four methods will be selected by using a
randomization scheme obtained from a sealed envelope : (1) negative pressure suction with 10
mL syringe and pushing the stylet; (2) negative pressure suction with 10 mL syringe and
injecting air; (3) without negative pressure suction and pushing the stylet; (4) without
negative pressure suction and injecting air. EUS FNA will be performed by two experienced
endosonographers. All specimens will be read by same experienced pathologist blinded to
methods.

The investigators will compare between the four groups in terms of adequacy, cellularity,
bloodiness, contamination, air artifact. The sensitivity, specificity, diagnostic accuracy,
positive predictive value, negative predictive value and statistical agreement for the
different methods will be calculated.