Department of Gastroenterology, Nanjing Drum Tower Hospital, Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
Department of Gastroenterology, Nanjing Drum Tower Hospital, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.
J Gastroenterol Hepatol. 2022 Oct;37(10):1975-1982. doi: 10.1111/jgh.15897. Epub 2022 Jun 3.
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the most established diagnostic method for pancreatic tissue. Rapid on-site evaluation by a trained endoscopist (self-ROSE) can improve the diagnostic accuracy. This research is aimed to analyze the application value of self-ROSE for EUS-FNA in solid pancreatic lesions.
A total of 194 consecutive patients with solid pancreatic lesions in Nanjing Drum Tower Hospital were randomized in a 1:1 ratio to EUS-FNA with or without self-ROSE in this single-center randomized controlled trial. Before initiating self-ROSE, the endoscopist underwent training for pancreatic cytologic sample adequacy assessment and cytopathological diagnosis of EUS-FNA in pathology department for 1 month. Some parts of the slides of EUS-FNA were air dried, stained on-site with BASO Liu's reagent, and on-site evaluated in self-ROSE group. Between the two groups, the diagnostic performance of EUS-FNA was analyzed, including sensitivity, specificity, positive predictive value, negative predictive value, and accuracy, with a comparison of the number of needle passes and the complication rates.
The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were 94.8%, 94.4%, 100%, 100%, and 58.3% in the self-ROSE group, respectively, and 70.1%, 65.1%, 100%, 100%, and 32.6% in the non-self-ROSE group. The diagnostic accuracy (P < 0.001) and sensitivity (P < 0.001) were both significantly increased during EUS-FNA in the self-ROSE group compared to the non-self-ROSE group. The rate of cytologic sample adequacy was 100% in self-ROSE group and 80.4% in non-self-ROSE group. The number of passes were 3.38 ± 1.00 in self-ROSE group and 3.22 ± 0.89 in non-self-ROSE group (P = 0.228). No complications were found in both. There was acceptable consistency between endoscopist and pathologist in the cytopathological diagnosis (kappa = 0.666, P < 0.05) and in the sample adequacy rate (kappa = 1.000, P < 0.001).
Our results demonstrated that self-ROSE is valuable for EUS-FNA in the diagnosis of solid pancreatic lesions and is an important choice to routinely increase the accuracy of EUS-FNA in centers without ROSE assessment.
内镜超声引导下细针抽吸术（EUS-FNA）是目前诊断胰腺组织的最成熟方法。经过培训的内镜医生进行现场快速评估（自我 ROSE）可以提高诊断准确性。本研究旨在分析自我 ROSE 在胰腺实性病变 EUS-FNA 中的应用价值。
这是一项单中心随机对照试验，共纳入 194 例南京鼓楼医院胰腺实性病变患者，按照 1:1 的比例随机分为 EUS-FNA 联合或不联合自我 ROSE 组。在开始自我 ROSE 之前，内镜医生在病理科接受了 1 个月的胰腺细胞学样本充足性评估和 EUS-FNA 细胞学诊断培训。EUS-FNA 的部分切片空气干燥后，用 BASO Liu 试剂现场染色，并在自我 ROSE 组进行现场评估。比较两组 EUS-FNA 的诊断性能，包括敏感性、特异性、阳性预测值、阴性预测值和准确率，并比较针数和并发症发生率。
自我 ROSE 组的准确率、敏感性、特异性、阳性预测值和阴性预测值分别为 94.8%、94.4%、100%、100%和 58.3%，非自我 ROSE 组分别为 70.1%、65.1%、100%、100%和 32.6%。自我 ROSE 组的诊断准确率（P<0.001）和敏感性（P<0.001）均明显高于非自我 ROSE 组。自我 ROSE 组的细胞学样本充足率为 100%，非自我 ROSE 组为 80.4%。自我 ROSE 组的穿刺次数为 3.38±1.00 次，非自我 ROSE 组为 3.22±0.89 次（P=0.228）。两组均未发生并发症。内镜医生和病理医生在细胞学诊断（kappa=0.666，P<0.05）和样本充足率（kappa=1.000，P<0.001）方面具有可接受的一致性。
本研究结果表明，自我 ROSE 有助于胰腺实性病变 EUS-FNA 的诊断，是提高无 ROSE 评估中心 EUS-FNA 准确性的重要选择。
