Abstract
BackgrouundFor 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.MethodsBetween 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.ResultsA 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%).ConclusionsOptical cell diagnosis of cervical or vaginal intraepithelial neoplasia using endocytoscopy provides a high level of diagnostic accuracy.Trial registrationThe study was registered with the UMIN database (ID: 000031712).UMIN000031712. Registered 16 March 2017,
Highlights
Cervical cancer is the 4th-most commonly diagnosed cancer (6.6% of total cases) and the 4th-leading cause of cancer death (7.5% of total cancer deaths) in women worldwide [1]
Colposcopy and biopsy were performed in 27 patients before enrolment, and cervical intraepithelial neoplasia (CIN) 3 or vaginal intraepithelial neoplasia (VAIN) 3 or worse was diagnosed in 21 patients
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) 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
Summary
Cervical cancer is the 4th-most commonly diagnosed cancer (6.6% of total cases) and the 4th-leading cause of cancer death (7.5% of total cancer deaths) in women worldwide [1]. According to the categories of the 2001 Bethesda system, patients with any kind of atypical squamous intraepithelial lesion of the uterine cervix or vagina are recommended by the American Society for Colposcopy and Cervical Pathology to receive colposcopy or an immediate loop electrosurgical excision procedure [2, 3]. Colposcopy and punch biopsy are common procedures for histological determination following cytology. The 2011 Japan Society of Gynecologic Oncology guidelines recommend cervical conization for patients with cervical intraepithelial neoplasia (CIN) 3 or worse lesions diagnosed by biopsy [4, 5]. Colposcopy-guided biopsy does not always provide high diagnostic accuracy [6, 7]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
