Effect of a stylet on a histological specimen in EUS-guided fine-needle tissue acquisition by using 22-gauge needles: a multicenter, prospective, randomized, controlled trial.
BACKGROUND
EUS-guided FNA (EUS-FNA) has become the most efficacious way to obtain specimens from a solid lesion adjacent to the GI tract. Previous reports regarding the use of a stylet during EUS-FNA were all based on cytological diagnosis and have showed no significant superiority in terms of diagnostic yield.


OBJECTIVE
To clarify the noninferiority of EUS-FNA without a stylet (S-) compared with EUS-FNA with a stylet (S+) on histological assessment.


METHODS
A prospective, single-blind, randomized, controlled crossover study.


METHODS
Five tertiary referral centers in Japan.


METHODS
Patients referred for EUS-FNA of a solid lesion.


METHODS
EUS-FNA S+ and S- in a total of 4 alternate passes with randomization to S+ first or S- first.


METHODS
The primary endpoint was the acquisition rate of an appropriate and sufficient specimen for histological assessment. The secondary endpoints were cellularity, contamination, bloodiness, diagnostic ability, and diagnostic accuracy.


RESULTS
We enrolled 107 patients (110 lesions) and analyzed 220 specimens each in the S+ and S- groups. The acquisition rate of appropriate and sufficient specimens in the S+ group was 121 of 220 (55.0%) and 122 of 220 (55.5%) in the S- group. The difference in the acquisition rate of the specimen (S- minus S+) based on the generalized estimating equation was 0.42% (95% confidence interval, -6.72% to 7.56%), which was less than 10% of the prespecified noninferiority margin of this study. With regard to cellularity, contamination, bloodiness score, diagnostic ability, and diagnostic accuracy, there were no significant differences between both groups. There were no dropouts in the study.


CONCLUSIONS
A variety of target lesions, multiple pathologists, lack of an assessment of intraobserver and interobserver variability, and a single-blind study for the pathologists.


CONCLUSIONS
EUS-FNA S- is noninferior to EUS-FNA S+ on histological assessment. (


BACKGROUND
UMIN000008695.).
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Yoko
Y
Abe
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Hiroshi
H
Kawakami
Research and Clinical Trial Center, Hokkaido University Hospital, Sapporo, Japan.
Koji
K
Oba
Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan.
Tsuyoshi
T
Hayashi
The First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
Ichiro
I
Yasuda
Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
Tsuyoshi
T
Mukai
Department of Gastroenterology, University of Tokyo, Tokyo, Japan.
Hiroyuki
H
Isayama
Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan.
Hirotoshi
H
Ishiwatari
The First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan.
Shinpei
S
Doi
Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
Masanori
M
Nakashima
Department of Gastroenterology, University of Tokyo, Tokyo, Japan.
Natsuyo
N
Yamamoto
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Masaki
M
Kuwatani
Department of Surgical Pathology, Hokkaido University Hospital, Sapporo, Japan.
Tomoko
T
Mitsuhashi
Department of Surgical Pathology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Tadashi
T
Hasegawa
Department of Tumor Pathology, Gifu University Hospital, Gifu, Japan.
Yoshinobu
Y
Hirose
Department of Pathology, Gifu Municipal Hospital, Gifu, Japan.
Tetsuya
T
Yamada
Department of Pathology, The University of Tokyo, Tokyo, Japan.
Mariko
M
Tanaka
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Naoya
N
Sakamoto
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D003937:Diagnosis, Differential; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009339:Needles; D018358:Neuroendocrine Tumors / Q000175:diagnosis*; D010179:Pancreas / Q000000981:diagnostic imaging / Q000473:pathology*; D010190:Pancreatic Neoplasms / Q000175:diagnosis*; D011446:Prospective Studies; D015203:Reproducibility of Results; D016037:Single-Blind Method