Comparison of High-Definition Electronic Magnifying Endoscopy With Image-Enhanced Technology Versus Colposcopy in the Detection of Cervical and Vaginal Lesions
Phase: NA
Conditions: Cervical Disease
Sponsor: West China Second University Hospital

Medical Research Ethics Committee of West China
Second University Hospital, Sichuan University
Version: V2.0, Date: March 4, 2026
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Comparative Study on the Efficacy of High-Definition Electronic
Amplification Endoscopy Combined with Image Enhancement
Technology and Colposcopy in the Exploration of Cervical and
Vaginal Pathologies
Research protocol
Project leaders:
Contact number:
Version: V2.0
Version date: March 4, 2026
I. Research Background
Colposcopy is currently an essential examination method for detecting cervical
and vaginal lesions. However, traditional colposcopy has low magnification and
limited field of view, resulting in limited identification of early cervical lesions.
According to existing research reports, the diagnostic accuracy of colposcopy for
low-grade lesions is only approximately 43.4%, while for high-grade lesions it
ranges from 59% to 76%. High-definition magnified electronic endoscopy (100–
150x) can clearly visualize microvessels and mucosal structures. In recent years,
gastrointestinal magnified endoscopy combined with image enhancement techniques
(e.g., NBI/BLI/LCI) has established a mature vascular and epithelial interpretation
system for early esophageal squamous cell carcinoma diagnosis. The cervical,
vaginal, and esophageal tissues share similar pathological evolution patterns of
precancerous lesions and early carcinogenesis due to their stratified squamous
epithelium. Theoretically, this technical system can be extended to the exploration of
lower genital tract lesions. Preliminary single-center, small-sample studies in Japan
suggest that this technology demonstrates superior diagnostic performance for
high-grade cervical lesions compared to traditional colposcopy, but high-quality
clinical validation remains lacking domestically. Therefore, this study aims to
systematically evaluate the diagnostic efficacy of high-definition magnified
electronic endoscopy combined with image enhancement techniques versus
traditional colposcopy through rigorous paired diagnostic trial design, aiming to

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Second University Hospital, Sichuan University
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provide clinicians with a more precise examination tool to address the limitations of
current methods. The goal is to establish an endoscopic atlas for cervical and vaginal
lesions and improve diagnostic accuracy.
II. Research Objective
1. Primary research objective: To compare the diagnostic accuracy of
high-definition electronic magnification endoscopy combined with image
enhancement technology versus colposcopy in detecting cervical and vaginal lesions.
2. Secondary research objectives: To evaluate and compare the sensitivity,
specificity, positive predictive value, and negative predictive value of the two
examinations, and to assess differences in imaging characteristics (e.g., lesion
boundary clarity and microvascular structure visualization) between the two
methods.
3. Research hypothesis: High-definition electronic magnification endoscopy
combined with image enhancement technology demonstrates superior diagnostic
accuracy for cervical and vaginal lesions compared to traditional colposcopy.
III. Research Content
3.1 Study Design
Study type: Paired diagnostic test design (diagnostic accuracy study with
intra-participant comparisons)
Randomization method: sequential randomization
Blind method: Open (blinding of personnel interpreting pathological diagnostic
results)
3.2 Multicenter studies (2)
Wang Ping, Zhou Shengtao (Department of Gynecology, West China Second
University Hospital, Sichuan University)
Liao Juan (Department of Gastroenterology, School of Public Health, Sichuan
University (West China Fourth Hospital))

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3.3 Study duration: March 2026 – March 2030
3.4 Sample Size and Calculation Basis
Based on research reports, the diagnostic accuracy of colposcopy for low-grade
lesions is only approximately 43.4%, while the diagnostic accuracy for high-grade
lesions ranges from 59% to 76%. A domestic multicenter study demonstrated that
traditional colposcopy has a specificity of 75.1% and a sensitivity of 70.2% in
detecting high-grade cervical lesions. Control group indicators (P0): According to
data, traditional colposcopy achieves a diagnostic accuracy of approximately
59-76% for high-grade lesions (HSIL+). The lower limit of 59% is adopted as the
calculation benchmark. Experimental group expected indicators (P1): It is
hypothesized that high-definition magnified electronic colposcopy can significantly
improve detection rates. A 20-percentage-point improvement is required to achieve
statistically significant clinical significance, with diagnostic accuracy potentially
reaching around 79%. Prevalence in target population: Literature reports indicate
that among participants undergoing colposcopy, the proportion of cases ultimately
pathologically confirmed as high-grade lesions (HSIL+) ranges from 20% to 40%,
with a set threshold of 30%. Statistical power (Power, 1-β): Set at 90%, with α =
0.05 (two-tailed).
Methods: Sample size estimation was performed using the sample size
calculation formula for paired design diagnostic tests (McNemar test). A minimum
of 212 study participants with complete paired data and valid gold standard results
were required, accounting for a dropout rate of 10%-20%. The final planned total
sample size was 270 cases.
Continuous enrollment was employed to include all eligible participants who
met the inclusion criteria and consented to participate in the study until the target
sample size was achieved. To balance potential biases arising from examination

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sequence, a simple randomization method was used to assign participants to two
distinct examination sequences (Sequence A group: initial observation and image
acquisition using a conventional optical colposcope (magnification 7.5-15x),
followed by endoscopy (preset magnification 90-120x); Sequence B group: initial
examination using an endoscope, followed by colposcopy).
3.5 Inclusion and exclusion criteria, withdrawal/termination criteria
Inclusion criteria: ①Age 18-65 years with indications for colposcopy
(HPV16/18 positive; HPV non-16/18 positive with LCT ≥ASCUS; HPV negative
with LCT ≥LSIL; persistent HPV infection ≥1 year). ②Voluntary signing of
informed consent form.
Exclusion criteria: ①Pregnant or lactating women. ②Acute genital tract
infections or severe coagulation disorders. ③History of radiotherapy for malignant
tumors or severe mental disorders in study participants. ④Minors.
Exit criteria: ①Requested withdrawal by study participants. ②Occurrence
of serious adverse events (e.g., major bleeding, allergic reactions).
3.6 Methods and Procedures
The same study participant was randomly assigned to groups A and B according
to sequence randomization, with examination sequences conducted in two groups.
Procedure for Evaluation Method 1 (Colposcopy): Study participants were
placed in the lithotomy position. After routine disinfection and draping, a speculum
was inserted. Traditional colposcopy was performed at designated time points (after
saline administration, 1 minute and 2 minutes post-acetic acid test, and post-iodine
test). The colposcopy specialist interpreted imaging features, recorded proposed
diagnostic opinions, and marked suspected lesion sites (denoted as Point Y). The
cervical surface was conceptualized as a clock face centered on the cervical os, with

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the 12 o'clock position representing the top of the cervix. For example, Y6 indicates
suspected cervical lesion at the 6 o'clock position under colposcopy.
Evaluation of Probe Method 2 (High-Definition Electronic Magnification
Endoscopy + Image Enhancement Technology): Procedure Flow: In the same study
participants, high-definition electronic magnification endoscopy combined with
image enhancement technology was used to observe the cervix and vagina and
acquire images at specified time points (after saline administration, 1 minute after
acetic acid test, 2 minutes after acetic acid test, and after iodine test). The
endoscopist interpreted the images based on characteristic features, recorded
proposed diagnostic opinions, and marked suspicious lesion sites on the schematic
diagram (denoted as N-point, e.g., N3 indicates suspected cervical lesion at point 3
under endoscopic evaluation; lesions simultaneously identified as suspicious by
colposcopy and endoscopy are labeled as T-point, e.g., T9 indicates suspected
cervical lesion at point 9 according to both examinations).
Biopsy specimens from suspicious sites (2-4 mm per tissue block, totaling 2-4 tissue
blocks) were submitted for examination. Endoscopists and colposcopists were
unaware of each other's interpretation results. Pathologists conducted microscopic
examination of the biopsy specimens and issued pathological diagnosis results
(pathologists were unaware of the grouping and proposed microscopic diagnosis
results).
For study participants who showed no suspicious lesions on conventional
colposcopy or endoscopy, informed consent was obtained to voluntarily opt for
biopsy. Those who chose biopsy had their pathological results compared with the
proposed microscopic diagnosis using the gold standard. Participants opting against
biopsy underwent 6-12 month follow-up HPV and TCT testing. Those with negative
follow-up HPV/TCT results, abnormal HPV/TCT findings, or persistent negative
results after colposcopy evaluation or colposcopic biopsy pathology were classified

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as true negatives (suboptimal microscopic diagnosis negative with follow-up gold
standard confirmation). Participants with ≥CINII or VAINII findings after 6-12
month colposcopic biopsy were categorized as false negatives (no suspicious lesions
detected microscopically but confirmed high-grade lesions by follow-up gold
standard). Image feature analysis was performed between experimental and control
groups, with accuracy validated through pathological or follow-up results. Adverse
events were recorded 24 hours post-examination (when vaginal swabs were removed
after biopsy) for participants undergoing both instrument-based examinations.
technology roadmap ：
3.7 Evaluation indicators:

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Primary outcome measure: accuracy rates of the two examinations, with
histopathological results or follow-up outcomes serving as the gold standard.
Secondary outcome indicators: sensitivity, specificity, positive predictive value,
negative predictive value, AUC, and lesion recognition rate (referring to the ability
to identify suspicious lesions through high-definition magnified endoscopy in cases
that are difficult to detect with conventional colposcopy).
Efficacy indicators: clarity of lesion margins and visualization capability of
microvascular structures (including resolution of point-like, clustered, and spiral
patterns), assessed using a 4-point Likert scale: 1=poor, 2=average, 3=good,
4=excellent.
Safety indicators: Examination-related adverse event incidence rate (e.g.,
bleeding, infection, mucosal injury or perforation during the procedure),
postoperative complication rate within 24 hours (e.g., lower abdominal discomfort,
vaginal bleeding, fever), and examination tolerance (assessing the proportion of
study participants who discontinued the examination midway or requested
termination of the procedure).
3.8 Data Management and Statistical Analysis
Data collection: Structured electronic case report forms were designed and
implemented for data acquisition, covering baseline characteristics, imaging features
and proposed diagnoses of the two examinations, biopsy information and
pathological results, follow-up records, and adverse event profiles.
Data entry and verification: Independent entry by two individuals, employing
logical consistency checks and scope verification, with disputed data corrected based
on original records.
When baseline measurement data conform to normal distribution, mean ±
standard deviation is used for description, and independent samples t-test is

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employed for intergroup comparisons. If normal distribution is not met, median
(interquartile range) is used for description, and Mann-Whitney U test is applied for
intergroup comparisons. For baseline categorical data, case count (percentage) is
used for description, and chi-square test or Fisher's exact test is utilized for
intergroup comparisons.
Primary outcome measures: The accuracy rates of both examinations were
calculated separately as (true positives + true negatives) / total cases. The difference
in accuracy rates between the two examinations was compared using a paired
chi-square test to determine statistical significance, with the calculated difference
and its 95% confidence interval (CI) reported. Sensitivity and specificity were
assessed using the McNemar test. For secondary outcome measures, count data
comparisons between groups were performed using chi-square tests, with rate
differences and their 95% CIs reported. When data followed a normal distribution,
independent samples t-tests were used for intergroup comparisons. For non-normally
distributed metric data, Mann-Whitney U tests were employed for intergroup
comparisons.
The incidence rate of adverse events was calculated as the total incidence rate
and the incidence rates of various events, with chi-square test or Fisher's exact test
used to compare intergroup differences.
Subgroup analysis was performed to evaluate the stability of the results, with all
findings presented as two-sided. A p-value <0.05 was considered statistically
significant.
4、Alternative diagnostic and therapeutic methods available
Study participants may opt out of this research without any adverse impact on
their access to conventional treatments. For this condition, standard therapeutic
approaches include: performing only traditional colposcopy, with biopsy taken when
necessary based on endoscopic findings to guide subsequent management plans. If

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biopsy is not required, regular follow-up examinations are recommended. Traditional
colposcopy has a long history and is performed by highly skilled practitioners, but its
imaging quality is suboptimal, resulting in poor visualization of the cervical canal.
This may lead to unnecessary biopsies and endocervical curettage (ECC).
5、Data Management and Information Confidentiality
During the study period, personal information such as the names and genders of
study participants will be replaced with codes or numbers and strictly confidential.
Only the relevant physicians will be aware of their data, ensuring robust protection
of participants' privacy rights. Study findings may be published in academic journals,
but no personal information of study participants will be disclosed.
If study participants consent to participate in this study, all their medical records
will be reviewed by relevant personnel from the research institution initiating this
study and relevant authoritative agencies, or by an independent ethics committee, to
assess the appropriateness of study procedures.
6、Adverse Event Management
Study participants required the insertion of specula and application of acetic
acid or iodine tincture to the cervical and vaginal mucosa. Biopsy may be necessary
when indicated. Mild pain, mucosal trauma, or slight vaginal bleeding are considered
normal phenomena. If major vaginal bleeding, allergic reactions, or infections occur
during or within 24 hours post-procedure (before follow-up completion) and cannot
be ruled out as unrelated to the procedure, they shall be classified as adverse events.
The procedure must be immediately discontinued, and the research team will provide
prompt medical intervention to participants while reporting the incident within 24
hours.
VII. Ethical Principles and Requirements for Life Sciences and Medical
Research

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This clinical study will comply with relevant regulations including the
Declaration of Helsinki issued by the World Medical Assembly and the Ethical
Review Guidelines for Life Science and Medical Research Involving Human
Subjects. Prior to enrollment, each study participant must sign an informed consent
form. Investigators are required to provide written explanations detailing the study's
objectives, nature, procedures, potential benefits, and risks in a comprehensive
manner, while ensuring participants are aware of their right to withdraw at any time.
All participants are fully informed prior to enrollment and given sufficient time to
consider participation. Participation is voluntary, and only those who have signed the
informed consent form will be included in the study.
VIII. Main References
[1]、LI Y, ZHANG Y, WANG F, et al. Improving colposcopic accuracy for cervical precancer detection: a retrospective
multicenter study in China[J]. Chinese Medical Journal, 2023, 136(10): 1201-1208.
[2]、KAWAGUCHI R, FUJIMOTO S, ISHII K, et al. Flexible magnifying endoscopy with narrow band imaging for the
diagnosis of uterine cervical tumors: A cooperative study among gastrointestinal endoscopists and gynecologists to explore a
novel microvascular classification system[J]. Journal of Obstetrics and Gynaecology Research, 2016, 42(8): 1006-1014.
[3]、URAOKA T, HIGASHI R, HORII J, et al. Characteristic findings of high‑ grade cervical intraepithelial neoplasia or
more on magnifying endoscopy with narrow band imaging[J]. Lasers in Surgery and Medicine, 2019, 51(5): 415-421.
[4]、SATO Y, OHASHI A, OTA H, et al. In vivo optical cellular diagnosis for uterine cervical or vaginal intraepithelial
neoplasia using flexible gastrointestinal endocytoscopy -a prospective pilot study-[J]. Journal of Gastroenterology, 2022, 57(5):
123-130