In vivo optical cellular diagnosis for uterine cervical or vaginal intraepithelial neoplasia using flexible gastrointestinal endocytoscopy -a prospective pilot study.
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.
['Ono|Shoko|S|http://orcid.org/0000-0002-4485-6367', 'Nozaki|Ayako|A|', 'Matsuda|Kana|K|', 'Takakuwa|Emi|E|', 'Sakamoto|Naoya|N|', 'Watari|Hidemichi|H|']
D000328:Adult D000368:Aged D018290:Cervical Intraepithelial Neoplasia D003127:Colposcopy D005260:Female D041981:Gastrointestinal Tract D006801:Humans D008875:Middle Aged D010865:Pilot Projects D011446:Prospective Studies D014625:Vaginal Neoplasms
Colposcopy ECA classification Endoscopes Cervical intraepithelial Neoplasia Vaginal neoplasms