Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
J Gastroenterol. 2019 Jun;54(6):501-510. doi: 10.1007/s00535-018-1527-2. Epub 2018 Nov 8.
Our previous studies have shown the diagnostic utility of a newly developed dual-focus endoscope with narrow-band imaging (DF-NBI) and simplified dyad criteria for detection of superficial esophageal squamous cell carcinoma (SESCC). This clinical trial aimed to study the diagnostic efficacy of DF-NBI with dyad criteria for detecting SESCC compared to white light imaging (WLI).
This was a single-arm prospective comparative trial. We enrolled 170 consecutive high-risk patients for esophageal squamous cell carcinoma. Patients were initially examined with WLI by one independent endoscopist and then the other performed DF-NBI blinded to the WLI diagnosis to avoid a carry-over effect. Lesions showing proliferation and/or various shapes of intrapapillary capillary loops (IPCL) under DF-NBI (i.e., dyad criteria) were endoscopically diagnosed as SESCC including high-grade intraepithelial neoplasia. The primary endpoint was sensitivity of WLI and DF-NBI for detecting SESCC. The secondary endpoints were the diagnostic performance (i.e., specificity and accuracy) and inter/intra-observer concordance of DF-NBI with dyad criteria.
A total 77 SESCCs were detected. The sensitivity of DF-NBI for SESCC was significantly higher than that of WLI (91% vs. 51%, P < 0.001). The specificity and accuracy of WLI and DF-NBI using dyad criteria were 100% vs. 84%, and 86% vs. 86%, respectively. Various shapes and proliferation of IPCL showed the highest value in inter-observer and intra-observer agreements (κ = 0.77 and 0.82, respectively).
DF-NBI combined with dyad criteria may be a promising technique with a high sensitivity for diagnosis of SESCC and high inter/intra-observer agreement.
我们之前的研究表明，一种新开发的具有窄带成像（DF-NBI）和简化二联体标准的双焦点内窥镜对于检测浅表性食管鳞状细胞癌（SESCC）具有诊断效用。本临床试验旨在研究与白光成像（WLI）相比，DF-NBI 联合二联体标准检测 SESCC 的诊断效能。
这是一项单臂前瞻性对照试验。我们纳入了 170 例连续的食管鳞状细胞癌高危患者。患者最初由一名独立的内镜医师进行 WLI 检查，然后另一名内镜医师在不了解 WLI 诊断的情况下进行 DF-NBI 检查，以避免携带效应。在 DF-NBI 下（即二联体标准）显示增生和/或各种形态的内乳头毛细血管袢（IPCL）的病变被内镜诊断为 SESCC，包括高级上皮内瘤变。主要终点是 WLI 和 DF-NBI 检测 SESCC 的敏感性。次要终点是 DF-NBI 联合二联体标准的诊断性能（即特异性和准确性）以及观察者内/间的一致性。
共检出 77 例 SESCC。DF-NBI 检测 SESCC 的敏感性明显高于 WLI（91% vs. 51%，P<0.001）。WLI 和 DF-NBI 联合二联体标准的特异性和准确性分别为 100% vs. 84%和 86% vs. 86%。IPCL 的各种形态和增生在观察者间和观察者内协议中具有最高的价值（κ=0.77 和 0.82）。
DF-NBI 联合二联体标准可能是一种很有前途的技术，具有高 SESCC 诊断敏感性和高观察者内/间一致性。
