Comparison of a 22-gauge Franseen-tip needle with a 20-gauge forward-bevel needle for the diagnosis of type 1 autoimmune pancreatitis: a prospective, randomized, controlled, multicenter study (COMPAS study)
Comparison of a 22-gauge Franseen-tip needle with a 20-gauge forward-bevel needle for the diagnosis of type 1 autoimmune pancreatitis: a prospective, randomized, controlled, multicenter study (COMPAS study)
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DOI：
10.1016/j.gie.2019.10.012
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发表时间：
2020-02-01
影响因子：
7.7
通讯作者：
Yazumi, Shujiro
中科院分区：
文献类型：
--
作者：
Kurita, Akira;Yasukawa, Satoru;Yazumi, Shujiro
背景和目的：使用EUS引导的FNA（EUS-FNA）对自身免疫性胰腺炎（AIP）进行组织学诊断是困难的。为了解决这个问题，最近开发了新的细针活检（FNB）针。在这里，我们前瞻性地评估了2个新设计的EUS-FNB针的组织学评价患者1型AIP.Methods：这是一个前瞻性的，随机的，多中心的试验比较活检标本获得与22号法兰针或20号前斜面针在疑似1型AIP患者。根据国际公认的诊断标准诊断AIP。主要终点是EUS-FNB针的灵敏度，次要终点是获得的标本量、基于淋巴浆细胞硬化性胰腺炎（LPSP）评估的胰腺组织学以及组织学结果对AIP诊断的贡献。结果：110名患者被随机分配到Franseen组（22号Franseen针）或前斜面组（20号前斜面针）。所有患者的EUS-FNB采样均成功。9例患者因AIP以外的诊断而被排除。与前斜面针相比，Franseen针获得的高倍视野数量明显更多。在101名患者中，Franseen组有39名患者（78%），前斜面组有23名患者（45%）被诊断为1级或2级LPSP（P = 0.001）。36例患者不能被诊断为1型AIP没有EUS-FNB标本results.Conclusions：22号法兰针应常规用于1型AIP的组织学诊断。
Background and Aims: Histologic diagnosis of autoimmune pancreatitis (AIP) using EUS-guided FNA (EUS-FNA) is difficult. To address this issue, new fine-needle biopsy (FNB) needles were recently developed. Here, we prospectively evaluated 2 newly designed EUS-FNB needles for histologic evaluation in patients with type 1 AIP.Methods: This was a prospective, randomized, multicenter trial comparing biopsy specimens obtained with a 22-gauge Franseen needle or a 20-gauge forward-bevel needle in patients with suspected type 1 AIP. AIP was diagnosed according to international consensus diagnostic criteria. The primary endpoint was the sensitivity of EUS-FNB needles, and secondary endpoints were the amount of specimen obtained, histology of the pancreas based on evaluation of lymphoplasmacytic sclerosing pancreatitis (LPSP), and contribution of histologic findings to the diagnosis of AIP.Results: One hundred ten patients were randomly assigned to the Franseen group (22-gauge Franseen needle) or the forward-bevel group (20-gauge forward-bevel needle). EUS-FNB sampling was successful in all patients. Nine patients were excluded because of diagnoses other than AIP. Compared with the forward-bevel needle, the Franseen needle obtained a significantly greater number of high-power fields. Of 101 patients, 39 patients (78%) in the Franseen group and 23 patients (45%) in the Forward-bevel group were diagnosed with level 1 or 2 LPSP (P = .001). Thirty-six patients could not be diagnosed with type 1 AIP without EUS-FNB specimen results.Conclusions: The 22-gauge Franseen needle should be routinely used for histologic diagnosis of type 1 AIP.