经黏膜下隧道活检与超声内镜引导下细针穿刺活检对胃上皮下病变的比较：一项采用交叉设计的前瞻性研究。
Comparison of submucosal tunneling biopsy versus EUS-guided FNA for gastric subepithelial lesions: a prospective study with crossover design.
作者信息
Kobara Hideki, Mori Hirohito, Nishimoto Naoki, Fujihara Shintaro, Nishiyama Noriko, Ayaki Maki, Yachida Tatsuo, Matsunaga Tae, Chiyo Taiga, Kobayashi Nobuya, Fujita Koji, Kato Kiyohito, Kamada Hideki, Oryu Makoto, Tsutsui Kunihiko, Iwama Hisakazu, Haba Reiji, Masaki Tsutomu
机构信息
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
Department of Clinical Research Support Center, Faculty of Medicine, Kagawa University, Kagawa, Japan.
出版信息
Endosc Int Open. 2017 Aug;5(8):E695-E705. doi: 10.1055/s-0043-112497. Epub 2017 Aug 3.
BACKGROUND AND STUDY AIMS
Endoscopic ultrasound-guided fine needle aspiration (FNA) for gastrointestinal subepithelial lesions (SELs) has limited diagnostic accuracy due to technical problems and small lesion size. We previously reported a novel submucosal tunneling biopsy (STB) technique for sampling SELs. This study aimed to evaluate the diagnostic ability and safety of STB compared to that of FNA for SELs.
PATIENTS AND METHODS
The study was a non-randomized, prospective comparative study with crossover design in patients with endoluminal gastric SELs. Forty-three patients, including 29 cases with lesions < 2 cm were enrolled. A crossover design with 2 intervention stages (Group A: FNA followed by STB for 23 SELs, Group B: STB followed by FNA for 20 SELs) was implemented. The primary outcome was the diagnostic yield (DY). Secondary outcomes were technical success rate, procedure time, complication rate, and sample quality.
RESULTS
The DY of STB was significantly higher than that of FNA (100 % vs. 34.8 %; < 0.0001) in group A, including 100 % in overall STB. The technical success rate of STB was significantly higher than that of FNA (100 % vs. 56.5 %; = 0.0006), whereas the median procedure time of STB was significantly longer than that of FNA (37 minutes vs. 18 minutes; < 0.0001). The median specimen area of STB samples was markedly larger than that of FNA samples (5.54 mm vs. 0.69 mm ; < 0.001). No complications occurred in either method.
CONCLUSIONS
STB had significantly superior diagnostic ability and a more adequate sample quality than FNA for endoluminal gastric SELs, indicating the suitability of STB for small SELs.
CLINICAL TRIAL REGISTRATION
UMIN 000006754.
背景与研究目的
由于技术问题和病变尺寸较小，内镜超声引导下细针穿刺抽吸术（FNA）对胃肠道上皮下病变（SELs）的诊断准确性有限。我们之前报道了一种用于SELs采样的新型黏膜下隧道活检（STB）技术。本研究旨在评估STB与FNA相比对SELs的诊断能力和安全性。
患者与方法
本研究是一项针对腔内胃SELs患者的非随机、前瞻性交叉设计比较研究。纳入43例患者，其中包括29例病变<2 cm的病例。实施了一个有2个干预阶段的交叉设计（A组：对23个SELs先进行FNA，然后进行STB；B组：对20个SELs先进行STB，然后进行FNA）。主要结局是诊断率（DY）。次要结局是技术成功率、操作时间、并发症发生率和样本质量。
结果
在A组中，STB的DY显著高于FNA（100%对34.8%；P<0.0001），包括总体STB的诊断率为100%。STB的技术成功率显著高于FNA（100%对56.5%；P = 0.0006），而STB的中位操作时间显著长于FNA（37分钟对18分钟；P<0.0001）。STB样本的中位标本面积明显大于FNA样本（5.54 mm²对0.69 mm²；P<0.001）。两种方法均未发生并发症。
结论
对于腔内胃SELs，STB的诊断能力明显优于FNA，且样本质量更充足，表明STB适用于小的SELs。
临床试验注册
UMIN 000006754。
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