University of Michigan, Ann Arbor, MI, United States.
Hopital Privé Jean Mermoz, Ramsay Generale de Sante, Lyon, France.
Pancreatology. 2022 Nov;22(7):994-1002. doi: 10.1016/j.pan.2022.08.012. Epub 2022 Aug 31.
Although emerging data evidences that EUS-guided needle-based confocal laser endomicroscopy (nCLE) accurately diagnoses pancreatic cystic lesions (PCLs), there are a lack of interobserver agreement (IOA) studies utilizing reference histopathological diagnosis and for specific PCL subtypes. Hence, we sought to assess the IOA, intra-observer reliability (IOR), and diagnostic performance of EUS-nCLE using a large cohort of patients with histopathological diagnosis amongst a broad panel of international observers.
EUS-nCLE videos (n = 76) of subjects with PCLs [intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystadenoma (SCA), pseudocyst, and cystic-neuroendocrine tumors/solid pseudopapillary neoplasm (cystic-NET/SPN)], simulating clinical prevalence rates were obtained from 3 prospective studies. An international panel of 13 endosonographers with nCLE experience, blinded to all PCL data, evaluated the video library twice with a two-week washout for PCL differentiation (mucinous vs. non-mucinous) and subtype diagnosis.
The IOA (κ = 0.82, 95% CI 0.77-0.87) and IOR (κ = 0.82, 95% CI 0.78-0.85) were "almost perfect" to differentiate mucinous vs. non-mucinous PCLs. For PCL subtype, IOA was highest for SCA (almost perfect; κ = 0.85), followed by IPMN (substantial, κ = 0.72), and cystic-NET/SPN (substantial, κ = 0.73). The IOA was moderate for MCN (κ = 0.47), and pseudocyst (κ = 0.57). Compared to histopathology, observers differentiated mucinous vs. non-mucinous PCLs with high accuracy (94.8%, 95% CI 93.3-96.1). For detecting specific PCLs subtypes, EUS-nCLE was highly accurate in diagnosing non-mucinous cysts (SCA: 98%; cystic-NET/SPN: 96%; pseudocyst: 96%) and slightly less accurate for mucinous lesions (IPMN: 86%; MCN: 84%).
Diagnosis of PCLs by EUS-nCLE guided virtual biopsy is very accurate and reliable for the most prevalent pancreatic cysts in clinical practice.
虽然新出现的数据表明,EUS 引导下的针式共聚焦激光内镜检查(nCLE)可以准确诊断胰腺囊性病变(PCL),但缺乏利用参考组织病理学诊断和特定 PCL 亚型的观察者间一致性(IOA)研究。因此,我们试图利用一组来自国际观察者的广泛面板的具有组织病理学诊断的患者的大队列来评估 EUS-nCLE 的 IOA、观察者内可靠性(IOR)和诊断性能。
从 3 项前瞻性研究中获得了 PCL [导管内乳头状黏液性肿瘤(IPMN)、黏液性囊腺瘤(MCN)、浆液性囊腺瘤(SCA)、假性囊肿和囊性神经内分泌肿瘤/实性假乳头状瘤(囊性-NET/SPN)]的 EUS-nCLE 视频(n=76),这些视频模拟了临床患病率。由 13 名具有 nCLE 经验的内镜超声医师组成的国际小组,对视频库进行了两次评估,两次评估之间有两周的洗脱期,用于 PCL 分化(黏液性与非黏液性)和亚型诊断。
IOA(κ=0.82,95%CI 0.77-0.87)和 IOR(κ=0.82,95%CI 0.78-0.85)在区分黏液性与非黏液性 PCL 方面为“几乎完美”。对于 PCL 亚型,SCA 的 IOA 最高(接近完美;κ=0.85),其次是 IPMN(实质;κ=0.72)和囊性-NET/SPN(实质;κ=0.73)。MCN 的 IOA 为中度(κ=0.47),假性囊肿的 IOA 为中度(κ=0.57)。与组织病理学相比,观察者对黏液性与非黏液性 PCL 的区分具有很高的准确性(94.8%,95%CI 93.3-96.1)。在检测特定的 PCL 亚型方面,EUS-nCLE 对诊断非黏液性囊肿(SCA:98%;囊性-NET/SPN:96%;假性囊肿:96%)非常准确,对黏液性病变的准确性略低(IPMN:86%;MCN:84%)。
EUS-nCLE 引导的虚拟活检对临床实践中最常见的胰腺囊肿进行 PCL 诊断非常准确和可靠。