EUS-FNA Clinical Trial
Official title:
Comparison of EUS-guided Fine Needle Aspiration Technique: Negative-pressure Suction With Syringe vs. Capillary Sampling With Stylet Slow-pull Technique
EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing pancreatic and peripancreatic solid masses. The aim of this study is to compare the two aspiration methods in EUS-FNA: negative-pressure suction with syringe vs. capillary sampling with stylet slow-pull technique. We will evaluate the diagnostic adequacy and accuracy of the specimens obtained by EUS-FNA with two aspiration methods.
EUS-guided fine needle aspiration (EUS-FNA) is a safe and effective method for diagnosing
pancreatic and peripancreatic solid masses. The diagnostic accuracy of EUS-FNA has been
reported to be 62-96%. There are two aspiration methods for obtaining specimens with EUS
needle, application of a negative-pressure syringe and capillary sampling (without suction).
The former method is thought to increase cellularity of obtained specimen. However, a
negative-pressure syringe can worsen the specimen quality by increasing the amount of bloody
material in the specimen and damaging the tissue. Blood in the aspirate dilutes the sample
and makes direct smears more difficult to interpret because clots form.
Meanwhile, the latter method might yield a small sample with a high diagnostic yield because
of a decreased amount of sanguineous staining. Recently, EUS-guided fine needle biopsy with
22-gauge ProCore needle using capillary sampling while removing the stylet slowly for 40 sec
during the to-and-fro movement of the needle (capillary sampling with style slow-pull
technique) for pancreas biopsy was reported to provide significantly higher tissue adequacy
compared to half- (5 mL) or full suction (10 mL) methods in animal study.
Therefore, we will perform the prospective randomized clinical trial comparing the
diagnostic adequacy and accuracy of the specimens obtained by two different aspiration
methods in EUS-FNA: negative-pressure suction with syringe (NPS) vs. capillary sampling with
stylet slow-pull technique (CSS).
The primary end point of this study is to evaluate the difference of diagnostic accuracy
between two aspiration methods. This study is a prospective randomized clinical trial. The
needle used in this study is a conventional EUS-FNA needle (Echotip, Cook Medical,
Winston-Salem, NC) approved by the FDA and Korea Food and Drug Administration (KFDA).
The procedure will be performed by one endoscopist. The patients will undergo EUS-FNA under
conscious sedation with midazolam and meperidine. The procedure is same as conventional
EUS-FNA except the aspiration method. The first aspiration method (NPS or CSS) will be
assigned by random number table. After first needle passage, the next EUS-FNA will be done
by different aspiration method. A total of four times of needle passes will be performed in
each patient with alternative aspiration methods (i.e., NPS and CSS each two times in one
patient).
Sample size
1. We Assumed that the diagnostic accuracy of two aspiration methods (NPS and CSS) are
equivalent (88%) and the non-inferiority margin is 10%.
2. A two-tailed sample size calculation was performed with 1% alpha error to attain 80%
power. Using a 10% dropout rate, the target sample size was 51 (i.e., NPS and CSS each
102 times in 51 patients).
Statistical analyses
1. Chi-square test - Comparing the specimen adequacy of 1st needle pass according to the
aspiration methods.
2. Student's t-test - Number of needle passes for optimal specimen and for accurate
diagnosis.
3. McNemar test - Comparing the diagnostic yields according to the aspiration methods.
4. Sensitivity, specificity, accuracy, positive and negative predictive values.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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