Division of Gastroenterology, Hepatology and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Pancreas Biliary Center, Gastrointestinal Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.
Gastrointest Endosc. 2017 Oct;86(4):644-654.e2. doi: 10.1016/j.gie.2017.03.002. Epub 2017 Mar 10.
EUS-guided needle-based confocal laser endomicroscopy (nCLE) characteristics of common types of pancreatic cystic lesions (PCLs) have been identified; however, surgical histopathology was available in a minority of cases. We sought to assess the performance characteristics of EUS nCLE for differentiating mucinous from non-mucinous PCLs in a larger series of patients with a definitive diagnosis.
Six endosonographers (nCLE experience >30 cases each) blinded to all clinical data, reviewed nCLE images of PCLs from 29 patients with surgical (n = 23) or clinical (n = 6) correlation. After 2 weeks, the assessors reviewed the same images in a different sequence. A tutorial on available and novel nCLE image patterns was provided before each review. The performance characteristics of nCLE and the κ statistic for interobserver agreement (IOA, 95% confidence interval [CI]), and intraobserver reliability (IOR, mean ± standard deviation [SD]) for identification of nCLE image patterns were calculated. Landis and Koch interpretation of κ values was used.
A total of 29 (16 mucinous PCLs, 13 non-mucinous PCLs) nCLE patient videos were reviewed. The overall sensitivity, specificity, and accuracy for the diagnosis of mucinous PCLs were 95%, 94%, and 95%, respectively. The IOA and IOR (mean ± SD) were κ = 0.81 (almost perfect); 95% CI, 0.71-0.90; and κ = 0.86 ± 0.11 (almost perfect), respectively. The overall specificity, sensitivity, and accuracy for the diagnosis of serous cystadenomas (SCAs) were 99%, 98%, and 98%, respectively. The IOA and IOR (mean ± SD) for recognizing the characteristic image pattern of SCA were κ = 0.83 (almost perfect); 95% CI, 0.73-0.92; and κ = 0.85 ± 0.11 (almost perfect), respectively.
EUS-guided nCLE can provide virtual histology of PCLs with a high degree of accuracy and inter- and intraobserver agreement in differentiating mucinous versus non-mucinous PCLs. These preliminary results support larger multicenter studies to evaluate EUS nCLE. (Clinical trial registration number: NCT02516488.).
已经确定了超声内镜引导下针式共聚焦激光显微内镜（nCLE）对常见胰腺囊性病变（PCL）类型的特征，但在少数情况下可获得手术组织病理学。我们旨在评估在更大系列具有明确诊断的患者中，EUS nCLE 区分黏液性与非黏液性 PCL 的性能特征。
六名内镜超声医师（nCLE 经验均>30 例）对所有临床数据进行盲法，回顾了 29 名患者的 EUS nCLE 图像，这些患者的诊断依据为手术（n=23）或临床（n=6）相关性。2 周后，评估者以不同的顺序查看相同的图像。在每次回顾之前，提供了有关可用和新型 nCLE 图像模式的教程。计算了 nCLE 的性能特征以及观察者间一致性（IOA，95%置信区间[CI]）和观察者内可靠性（IOR，平均值±标准差[SD]）的κ 统计量，用于识别 nCLE 图像模式。使用 Landis 和 Koch 解释κ 值。
共回顾了 29 名患者（16 名黏液性 PCL 患者，13 名非黏液性 PCL 患者）的 29 个 nCLE 患者视频。黏液性 PCL 诊断的总体敏感性、特异性和准确性分别为 95%、94%和 95%。IOA 和 IOR（平均值±SD）分别为κ=0.81（几乎完美）；95%CI，0.71-0.90；和κ=0.86±0.11（几乎完美）。浆液性囊腺瘤（SCA）诊断的总体特异性、敏感性和准确性分别为 99%、98%和 98%。识别 SCA 特征性图像模式的 IOA 和 IOR（平均值±SD）分别为κ=0.83（几乎完美）；95%CI，0.73-0.92；和κ=0.85±0.11（几乎完美）。
EUS 引导的 nCLE 可以提供 PCL 的虚拟组织学，在区分黏液性与非黏液性 PCL 方面具有高度准确性和观察者间及观察者内一致性。这些初步结果支持更大的多中心研究来评估 EUS nCLE。（临床试验注册号：NCT02516488.）。
