使用25号针在超声内镜引导下细针组织获取中高低负压吸引技术：一项多中心、前瞻性、随机、对照试验
High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial.
作者信息
Kudo Taiki, Kawakami Hiroshi, Hayashi Tsuyoshi, Yasuda Ichiro, Mukai Tsuyoshi, Inoue Hiroyuki, Katanuma Akio, Kawakubo Kazumichi, Ishiwatari Hirotoshi, Doi Shinpei, Yamada Reiko, Maguchi Hiroyuki, Isayama Hiroyuki, Mitsuhashi Tomoko, Sakamoto Naoya
机构信息
Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan.
出版信息
Gastrointest Endosc. 2014 Dec;80(6):1030-7.e1. doi: 10.1016/j.gie.2014.04.012. Epub 2014 Jun 2.
BACKGROUND
EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial.
OBJECTIVE
To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles.
DESIGN
Prospective, single-blind, randomized, controlled crossover trial.
SETTING
Seven tertiary referral centers.
PATIENTS
Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist.
INTERVENTION
EUS-FNA by using NNP and HNP.
MAIN OUTCOME MEASUREMENTS
The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP.
RESULTS
We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis (P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved (P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy.
LIMITATIONS
This was a single-blinded, crossover study.
CONCLUSION
Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. (
CLINICAL TRIAL REGISTRATION NUMBER
UMIN000005939.).
背景
超声内镜引导下细针穿刺抽吸术（EUS-FNA）对胰腺疾病具有较高的诊断准确性。然而，尽管大多数报告通常聚焦于细胞学检查，但组织学组织质量很少被研究。最近有研究表明，EUS-FNA联合高负压（HNP）抽吸在获取组织方面具有有效性，但迄今为止尚未在前瞻性随机临床试验中得到验证。
目的
使用25G穿刺针评估EUS-FNA联合HNP对胰腺病变进行组织学诊断的充分性。
设计
前瞻性、单盲、随机、对照交叉试验。
地点
7家三级转诊中心。
患者
因胰腺实性病变接受EUS-FNA检查的患者。2011年7月至2012年4月，90例患者分别使用正常负压（NNP）和HNP对胰腺实性肿块进行EUS-FNA，各穿刺2次。穿刺顺序随机，样本的充分性、质量和组织学由一名专业病理专家评估。
干预措施
使用NNP和HNP进行EUS-FNA。
主要观察指标
使用EUS-FNA联合HNP技术获取组织的充分性以及组织学诊断的准确性。
结果
我们发现，分别使用NNP和HNP获取的标本中，72.2%（65/90）和90%（81/90）足以进行组织学诊断（McNemar检验，P = 0.0003）。分别使用NNP和HNP获取的标本中，73.3%（66/90）和82.2%（74/90）获得了准确诊断（McNemar检验，P = 0.06）。1例患者术后发生胰腺炎，经保守治疗后缓解。
局限性
这是一项单盲交叉研究。
结论
EUS-FNA联合HNP技术的活检程序在获取组织方面优于EUS-FNA联合NNP程序。（临床试验注册号：UMIN000005939。）
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