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In vivo optical cellular diagnosis for uterine cervical or vaginal intraepithelial neoplasia using flexible gastrointestinal endocytoscopy -a prospective pilot study-
Shoko Ono
Hokkaido Daigaku Byoin
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4485-6367
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This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Cancer.
Background 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, https://rctportal.niph.go.jp/detail/um?trial_id=UMIN000031712
Keywords
Cervical Intraepithelial Neoplasia, Colposcopy, Vaginal Neoplasms, Endoscopes, ECA classification
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Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
- Endocytoscopyprocedure1.mp4
Additional file 1 The procedure of endocytoscopy for cervix. After staining using 0.1% methylene blue, malignant area is focuses by endocytoscopy. Target biopsy is obtained, and surrounding area is focused. ECS 5 (increase of the ratio of nucleus ± cytoplasm and irregular arrangement of enlarged and blurred nuclei) in malignant area and ECS 3 (Increase of cells without enlarged nuclei) in surrounding area are observed.
- Supple1.TIF
Supplement figure. Enrollment flowchart.
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This preprint is under consideration at BMC Cancer. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
In vivo optical cellular diagnosis for uterine cervical or vaginal intraepithelial neoplasia using flexible gastrointestinal endocytoscopy -a prospective pilot study-
Shoko Ono
Hokkaido Daigaku Byoin
Corresponding Author
ORCiD: https://orcid.org/0000-0002-4485-6367
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 28 Sep, 2020
Version (no preprint)
Posted 19 Aug, 2020
Editor assigned
On 16 Sep, 2020
Submission checks complete
On 15 Sep, 2020
Editor invited
On 15 Sep, 2020
This version was not preprinted
No comments provided
Review #1 received
Received 09 Sep, 2020
Reviewer #3 agreed
On 02 Sep, 2020
Reviewer #2 agreed
On 30 Aug, 2020
Review #2 received
Received 30 Aug, 2020
Editor assigned
On 17 Aug, 2020
Reviewers invited
Invitations sent on 17 Aug, 2020
Reviewer #1 agreed
On 17 Aug, 2020
Submission checks complete
On 16 Aug, 2020
Editor invited
On 16 Aug, 2020
First submitted
On 11 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at BMC Cancer.
Background 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, https://rctportal.niph.go.jp/detail/um?trial_id=UMIN000031712
Figure 1
Figure 2
Figure 3