Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions
Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions
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DOI：
10.1016/j.gie.2012.03.1392
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发表时间：
2012-08-01
影响因子：
7.7
通讯作者：
Varadarajulu, Shyam
中科院分区：
文献类型：
--
作者：
Bang, Ji Young;Hebert-Magee, Shantel;Varadarajulu, Shyam
背景：为了克服细胞学的局限性，已经开发了活检针来获取EUS期间的组织学样本。目的：比较22号(G) FNA和22G活检针（FNB）在eus引导下活检胰腺实性肿块的效果。设计：随机试验。环境：三级医疗中心。患者：本研究涉及56例实性胰腺肿块患者。干预措施：采用22G FNA或22G FNB装置取样胰腺肿块。主要结果测量：比较建立诊断所需的中位数，诊断充分性，技术性能，并发症发生率，组织学核心的获取和组织学标本的质量。结果：28例患者随机分为FNA组和FNB组。FNA和FNB针在确定诊断所需的中位数通过次数（1[四分位数范围1-2.5]vs 1[四分位数范围1-1]；P = 0.21）、诊断充分率（100% vs 89.3%; P = 0.24）、技术失败（0 vs 3.6%; P = 1.0）或并发症（两者均为3.6%）方面分别无显著差异。在FNA和FNB队列中，在第1、2和3阶段确诊的患者分别为64.3%对67.9%，10.7%对17.9%，25%对3.6%。FNA组和FNB组在获取组织学核心（100% vs 83.3%, P = 0.26）或诊断性组织学标本（66.7% vs 80%, P = 0.66）方面分别无显著差异。局限性：仅评估胰腺肿块。结论：FNA针和FNB针的诊断充分性、技术性能和安全性具有可比性。两种针型在组织学核心的产量和质量上无显著差异。（临床试验注册号：AQ:NCT01394159）（胃肠内窥镜，2012;76:321-7）
Background: To overcome limitations of cytology, biopsy needles have been developed to procure histologic samples during EUS.Objective: To compare 22-gauge (G) FNA and 22G biopsy needles (FNB) for EUS-guided sampling of solid pancreatic masses.Design: Randomized trial.Setting: Tertiary-care medical center.Patients: This study involved 56 patients with solid pancreatic masses.Intervention: Sampling of pancreatic masses by using 22G FNA or 22G FNB devices.Main Outcome Measurements: Compare the median number of passes required to establish the diagnosis, diagnostic sufficiency, technical performance, complication rates, procurement of the histologic core, and quality of the histologic specimen.Results: A total of 28 patients were randomized to the FNA group and 28 to the FNB group. There was no significant difference in median number of passes required to establish the diagnosis (1 [interquartile range 1-2.5] vs 1 [interquartile range 1-1]; P = .21), rates of diagnostic sufficiency (100% vs 89.3%; P = .24), technical failure (0 vs 3.6%; P = 1.0), or complications (3.6% for both) between FNA and FNB needles, respectively. Patients in whom diagnosis was established in passes 1, 2, and 3 were 64.3% versus 67.9%, 10.7% versus 17.9%, and 25% versus 3.6%, respectively, for FNA and FNB cohorts. There was no significant difference in procurement of the histologic core (100% vs 83.3%; P = .26) or the presence of diagnostic histologic specimens (66.7% vs 80%; P = .66) between FNA and FNB cohorts, respectively.Limitations: Only pancreatic masses were evaluated.Conclusion: Diagnostic sufficiency, technical performance, and safety profiles of FNA and FNB needles are comparable. There was no significant difference in yield or quality of the histologic core between the 2 needle types. (Clinical trial registration number: AQ:NCT01394159.) (Gastrointest Endosc 2012;76:321-7.)