Operative Endoscopy Department, Campus Bio-Medico University Hospital, Rome, Italy.
Pathology Unit, Campus Bio-Medico University Hospital, Rome, Italy.
Gastrointest Endosc. 2021 Sep;94(3):562-568.e1. doi: 10.1016/j.gie.2021.03.029. Epub 2021 Mar 31.
EUS fine-needle biopsy (EUS-FNB) sampling is the standard procedure for diagnosis of pancreatic lesions. Fluorescence confocal microscopy (FCM) allows imaging of tissues in the fresh state, requiring minimal preparation without damage or loss of tissue. Until now, no data exist on FCM in the field of microhistologic specimens. We aimed to assess the diagnostic performance of FCM in predicting histologic adequacy of EUS-FNB samples in pancreatic solid lesions and to assess the agreement between FCM evaluation and final histology.
In this single-center prospective study on consecutive patients with pancreatic lesions receiving EUS-FNB, the obtained samples have been evaluated at FCM and classified as "inadequate" or "adequate" (benign, suspicious, or malignant). The kappa test was used to quantify agreement. The diagnostic accuracy of FCM was assessed. A P < .05 was considered to be statistically significant.
From April 2020 to September 2020, 81 patients were enrolled. In all cases FCM showed the macro image of the sample and created a digital image. Of the samples, 92.6% was defined as adequate at the FCM evaluation and confirmed at histopathology. Histologic diagnoses were 8% benign, 17.3% atypical/suspicious, and 74.7% malignant with satisfactory agreement with the FCM evaluation (Cohen's κ coefficient, .95; 95% confidence interval [CI], .89-1.01; P = .001). The sensitivity of the FCM evaluation was 100% (95% CI, 95%-100%), specificity 66.7% (95% CI, 22.3%-95.7%), accuracy 97% (95% CI, 90.7%-99.7%), positive predictive value 97% (95% CI, 91.8%-99%), and negative predictive value 100%.
FCM represents a new technique successfully applicable to microhistologic specimens. It provides fast information about sample adequacy in small specimens with good agreement in the final histology.
EUS 细针活检（EUS-FNB）采样是诊断胰腺病变的标准程序。荧光共聚焦显微镜（FCM）允许对新鲜状态下的组织进行成像，需要的准备工作最少，不会造成组织损伤或丢失。到目前为止，FCM 在微观标本领域尚无数据。我们旨在评估 FCM 在预测胰腺实体病变 EUS-FNB 样本组织学充分性方面的诊断性能，并评估 FCM 评估与最终组织学之间的一致性。
在这项对接受 EUS-FNB 的胰腺病变连续患者进行的单中心前瞻性研究中，对获得的样本进行 FCM 评估，并分为“不充分”或“充分”（良性、可疑或恶性）。使用 Kappa 检验来量化一致性。评估 FCM 的诊断准确性。P<.05 被认为具有统计学意义。
从 2020 年 4 月至 2020 年 9 月，共纳入 81 例患者。在所有情况下，FCM 均显示样本的宏观图像并创建数字图像。在 FCM 评估中，92.6%的样本被定义为充分，并在组织病理学上得到证实。组织学诊断为 8%良性、17.3%非典型/可疑和 74.7%恶性，与 FCM 评估具有良好的一致性（Cohen's κ 系数，.95；95%置信区间 [CI]，.89-1.01；P=.001）。FCM 评估的敏感性为 100%（95%CI，95%-100%），特异性为 66.7%（95%CI，22.3%-95.7%），准确性为 97%（95%CI，90.7%-99.7%），阳性预测值为 97%（95%CI，91.8%-99%），阴性预测值为 100%。
FCM 是一种新技术，可成功应用于微观标本。它提供了关于小标本中样本充分性的快速信息，与最终组织学具有良好的一致性。
