应用于宫颈或阴道上皮内瘤变的活体光学细胞诊断——一种采用软性胃肠道内镜的前瞻性初步研究。
In vivo optical cellular diagnosis for uterine cervical or vaginal intraepithelial neoplasia using flexible gastrointestinal endocytoscopy -a prospective pilot study.
机构信息
Department of Gastroenterology, Hokkaido University Hospital, Nishi-4, Kita-15, Kita-ku, Sapporo, 060-8648, Japan.
Department of Obstetrics and Gynecology, Hokkaido University Hospital, Nishi-4, Kita-15, Kita-ku, Sapporo, 060-8648, Japan.
出版信息
BMC Cancer. 2020 Oct 2;20(1):955. doi: 10.1186/s12885-020-07460-6.
BACKGROUUND
For patients with any kind of atypical squamous intraepithelial lesion of the uterine cervix or vagina, colposcopy and punch biopsy are common procedures for histological determination following cytology. However, colposcopy-guided biopsy does not provide a high level of diagnostic accuracy. The aim of this study was to determine the usefulness of optical biopsy in vivo using endocytoscopy compared with conventional procedures using colposcopy.
METHODS
Between May 2018 and March 2019, patients who were scheduled for cervical conization or mapping biopsies of the vagina were prospectively enrolled. Endocytoscopy was performed by senior endoscopists prior to scheduled procedures, and endocytoscopic images and biopsy samples were taken from the most prominent site and surrounding area of the cervical or vaginal lesions. The collection process of images was randomized and anonymous, and three doctors separately evaluated the images according to the ECA classification. ECA 4 and 5 are indicative of endoscopic malignancy. The primary endpoint was diagnostic accuracy (benign or malignant: cervical intraepithelial neoplasia (CIN) 3 or vaginal intraepithelial neoplasia (VAIN) 3 or worse) of cell images at the most prominent site in each patient.
RESULTS
A total of 28 consecutive patients were enrolled. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of endocytoscopic images were 95.0% (84.8-98.6%), 87.5% (61.9-96.5%), 95.0% (84.8-98.6%), 87.5% (61.9-96.5%) and 92.9% (78.2-98.0%), respectively. Inter-observer agreement among three reviewers was 0.78 (0.08-9.88, P < 0.01). On the other hand, the accuracy of colposcopy-guided biopsy was 74.1% (64.0-84.0%).
CONCLUSIONS
Optical cell diagnosis of cervical or vaginal intraepithelial neoplasia using endocytoscopy provides a high level of diagnostic accuracy.
TRIAL REGISTRATION
The study was registered with the UMIN database (ID: 000031712 ). UMIN000031712 . Registered 16 March 2017.
背景
对于任何类型的子宫颈或阴道不典型鳞状上皮内病变患者，细胞学检查后，阴道镜检查和宫颈活检是进行组织学诊断的常用方法。然而，阴道镜引导下活检并不能提供高诊断准确性。本研究旨在通过与阴道镜检查比较，确定使用内镜细胞检查术进行体内光学活检的有用性。
方法
2018 年 5 月至 2019 年 3 月，前瞻性纳入计划行宫颈锥切术或阴道图谱活检的患者。在计划的手术前，由资深内镜医生进行内镜细胞检查术，从宫颈或阴道病变最明显的部位和周围区域采集内镜细胞检查图像和活检样本。图像采集过程是随机和匿名的，三位医生分别根据 ECA 分类评估图像。ECA4 和 5 提示内镜下恶性。主要终点是每位患者最明显部位的细胞图像的诊断准确性（良性或恶性：宫颈上皮内瘤变（CIN）3 或阴道上皮内瘤变（VAIN）3 或更差）。
结果
共纳入 28 例连续患者。内镜细胞检查图像的敏感性、特异性、阳性预测值、阴性预测值和准确性分别为 95.0%（84.8-98.6%）、87.5%（61.9-96.5%）、95.0%（84.8-98.6%）、87.5%（61.9-96.5%）和 92.9%（78.2-98.0%）。三位观察者之间的观察者间一致性为 0.78（0.08-9.88，P<0.01）。另一方面，阴道镜引导下活检的准确性为 74.1%（64.0-84.0%）。
结论
使用内镜细胞检查术对宫颈或阴道上皮内瘤变进行光学细胞诊断可提供较高的诊断准确性。
试验注册
本研究已在 UMIN 数据库注册（注册号：000031712）。UMIN000031712。注册于 2017 年 3 月 16 日。
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