Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama, Japan.
Endoscopy. 2013;45(2):98-105. doi: 10.1055/s-0032-1325932. Epub 2013 Jan 10.
Endocytoscopy enables observation at 450-fold magnification during gastrointestinal endoscopy, allowing on-site "optical biopsy." We compared the accuracies of endocytoscopy and standard biopsy for the diagnosis of colorectal neoplasms.
We performed a randomized, controlled, open-label trial of patients with colorectal lesions (≥ 5 mm) detected during colonoscopy in a tertiary referral center. We randomly assigned the 203 detected lesions of 170 eligible patients to either the endocytoscopy or standard biopsy group. An on-site endoscopist assessed the histopathology of the endocytoscopy group lesions according to the endocytoscopic findings, whereas a pathologist later assessed standard biopsy group lesions by microscopic examination of the biopsy specimens. We calculated the diagnostic accuracies in both groups with reference to the final histopathology of the resected specimens. The primary endpoint was to determine whether the diagnostic accuracy of endocytoscopy for neoplastic lesions was noninferior to that of standard biopsy (with a predefined noninferiority margin of 10%). Analyses were by intention-to-treat and per-protocol. The study is registered, number UMIN000003923.
Overall, 102 lesions in the endocytoscopy group and 101 in the standard biopsy group were available for primary outcome analysis. There were no complications. The diagnostic accuracy of endocytoscopy for the discrimination of neoplastic lesions was 94.1% (95% confidence interval 87.6% to 97.8%), whereas that of standard biopsy was 96.0% (90.2% to 98.9%), which is within the noninferiority margin (absolute difference -1.9%, -8.6% to +5.0%).
Endocytoscopy is noninferior to standard biopsy for the discrimination of neoplastic lesions. With its advantage of providing an on-site diagnosis, endocytoscopy could provide a novel alternative to standard biopsy in routine colonoscopy.
内镜下细胞学检查可在胃肠内镜检查时提供 450 倍放大倍率的观察，实现现场“光学活检”。我们比较了内镜下细胞学检查和标准活检对结直肠肿瘤的诊断准确性。
我们在一家三级转诊中心进行了一项随机、对照、开放性临床试验，纳入结肠镜检查发现的直径≥5mm 的结直肠病变患者。我们将 170 例符合条件的患者的 203 个检测到的病变随机分配至内镜下细胞学检查组或标准活检组。现场内镜医生根据内镜下细胞学检查的结果评估内镜下细胞学检查组病变的组织病理学，而病理医生则通过对活检标本的显微镜检查评估标准活检组病变。我们参考切除标本的最终组织病理学结果，计算两组的诊断准确性。主要终点是确定内镜下细胞学检查对肿瘤性病变的诊断准确性是否不劣于标准活检（预设的非劣效性边界为 10%）。分析采用意向治疗和方案分析。该研究已注册，注册号 UMIN000003923。
总体而言，内镜下细胞学检查组有 102 个病变和标准活检组有 101 个病变可用于主要结局分析。两组均无并发症。内镜下细胞学检查用于鉴别肿瘤性病变的诊断准确性为 94.1%（95%置信区间 87.6%至 97.8%），而标准活检的诊断准确性为 96.0%（90.2%至 98.9%），在非劣效性边界内（绝对差值-1.9%，-8.6%至+5.0%）。
内镜下细胞学检查与标准活检相比，在鉴别肿瘤性病变方面不劣效。由于其具有提供现场诊断的优势，内镜下细胞学检查可能成为常规结肠镜检查中标准活检的一种新选择。
