Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: a prospective, single blind, randomized, controlled trial.
BACKGROUND
Use of a stylet during EUS-guided FNA (EUS-FNA) is believed to improve the quality and diagnostic yield of specimens.


OBJECTIVE
To compare samples obtained by EUS-FNA with (S+) and without (S-) a stylet for diagnostic yield of malignancy and cytological characteristics.


METHODS
Randomized, controlled trial.


METHODS
Tertiary referral center.


METHODS
Consecutive patients referred for EUS-FNA of solid lesions.


METHODS
EUS-FNA; the number of passes was determined by lesion site (6 pancreas/others and 4 lymph nodes).


METHODS
Diagnostic yield of malignancy and degree of cellularity, specimen adequacy, contamination, and amount of blood.


RESULTS
One hundred patients were prospectively enrolled in this randomized, controlled trial and the sites of EUS-FNA were the pancreas, 58; lymph node, 25; and other, 17. The overall diagnosis was malignancy in 56, benign in 30, suspicious/atypical in 7, and inadequate specimen in 7 lesions. There were 550 passes made (275 with a stylet and 275 without a stylet). Interim analysis demonstrated no difference in the diagnostic yield of malignancy (94 passes with a stylet [34.2%] vs 110 without a stylet [40%], P = .2) and in the proportion of inadequate specimens (57 with a stylet [20.7%] vs 64 without a stylet [23.3%], P = .2). There was no difference with regard to cellularity (P = .83), contamination (P = .31), number of cells (P = .25), and amount of blood (P = .6). Similar results were noted in a subgroup analysis based on lesion site. Applying the rules of futility, the study was terminated.


CONCLUSIONS
Subjectivity in cytopathologists' assessment, endosonographer not blinded.


CONCLUSIONS
There was no difference in the diagnostic yield of malignancy or proportion of inadequate specimens between passes with and without a stylet. These results suggest that the use of a stylet does not confer any advantage during EUS-FNA.
Department of Medicine, Washington University, St. Louis, Missouri 63110, USA.
Sachin
S
Wani
Dayna
D
Early
Julie
J
Kunkel
Ann
A
Leathersich
Christine E
CE
Hovis
Thomas G
TG
Hollander
Cara
C
Kohlmeier
Cynthia
C
Zelenka
Riad
R
Azar
Steven
S
Edmundowicz
Brian
B
Collins
Jingxia
J
Liu
Matthew
M
Hall
Daniel
D
Mullady
D000005:Abdomen; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology*; D008297:Male; D008482:Mediastinum; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010179:Pancreas / Q000000981:diagnostic imaging / Q000473:pathology*; D010190:Pancreatic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology*; D011446:Prospective Studies; D016037:Single-Blind Method