Abe Yoko, Kawakami Hiroshi, Oba Koji, Hayashi Tsuyoshi, Yasuda Ichiro, Mukai Tsuyoshi, Isayama Hiroyuki, Ishiwatari Hirotoshi, Doi Shinpei, Nakashima Masanori, Yamamoto Natsuyo, Kuwatani Masaki, Mitsuhashi Tomoko, Hasegawa Tadashi, Hirose Yoshinobu, Yamada Tetsuya, Tanaka Mariko, Sakamoto Naoya
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Research and Clinical Trial Center, Hokkaido University Hospital, Sapporo, Japan.
Gastrointest Endosc. 2015 Nov;82(5):837-844.e1. doi: 10.1016/j.gie.2015.03.1898. Epub 2015 May 1.
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.
To clarify the noninferiority of EUS-FNA without a stylet (S-) compared with EUS-FNA with a stylet (S+) on histological assessment.
A prospective, single-blind, randomized, controlled crossover study.
Five tertiary referral centers in Japan.
Patients referred for EUS-FNA of a solid lesion.
EUS-FNA S+ and S- in a total of 4 alternate passes with randomization to S+ first or S- first.
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.
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.
A variety of target lesions, multiple pathologists, lack of an assessment of intraobserver and interobserver variability, and a single-blind study for the pathologists.
EUS-FNA S- is noninferior to EUS-FNA S+ on histological assessment. (
UMIN000008695.).
超声内镜引导下细针穿刺抽吸术（EUS-FNA）已成为获取胃肠道相邻实性病变标本的最有效方法。以往关于EUS-FNA期间使用穿刺针芯的报道均基于细胞学诊断，在诊断率方面未显示出显著优势。
阐明在组织学评估中，无穿刺针芯的EUS-FNA（S-）与有穿刺针芯的EUS-FNA（S+）相比是否非劣效。
一项前瞻性、单盲、随机、对照交叉研究。
日本的五个三级转诊中心。
因实性病变接受EUS-FNA检查的患者。
EUS-FNA的S+和S-总共交替进行4次穿刺，随机决定先进行S+或先进行S-。
主要终点是获取适合组织学评估的充足标本的成功率。次要终点包括细胞数量、污染情况、血性程度、诊断能力和诊断准确性。
我们纳入了107例患者（110个病变），并对S+组和S-组各220份标本进行了分析。S+组获取适合且充足标本的成功率为220份中的121份（55.0%），S-组为220份中的122份（55.5%）。基于广义估计方程得出的标本获取率差异（S-减去S+）为0.42%（95%置信区间为-6.72%至7.56%），低于本研究预先设定的非劣效界值的10%。在细胞数量、污染情况、血性评分、诊断能力和诊断准确性方面，两组之间无显著差异。研究中无患者退出。
病变类型多样、有多位病理学家参与、缺乏对观察者内和观察者间变异性的评估，以及针对病理学家的单盲研究。
在组织学评估中，EUS-FNA的S-不劣于EUS-FNA的S+。（临床试验注册号：UMIN000008695。）
