1. Primary Objective: To compare the diagnostic accuracy of high-definition electronic magnifying endoscopy combined with image-enhanced technology versus colposcopy for cervical and vaginal lesions. 2. Secondary Objectives: To evaluate and compare the sensitivity, specificity, positive predictive value, and negative predictive value of the two examination methods, and to assess the differences between the two techniques in image characteristics, such as lesion border clarity and visualization of microvascular structures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
270
High-definition magnifying endoscopy (100-150×) enables clear visualization of microvascular and mucosal structures. In recent years, magnifying endoscopy combined with image-enhanced techniques (such as NBI/BLI/LCI) has established a well-developed vascular and epithelial interpretation system for the diagnosis of early esophageal squamous cell carcinoma. The cervix, vagina, and esophagus share the same stratified squamous epithelium, and the pathological evolution of precancerous lesions and early cancer exhibits similarities. Therefore, this technical framework may theoretically be transferable to the detection of lower genital tract lesions.
diagnostic accuracy
Time frame: At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.
Sensitivity
Time frame: At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.
Specificity
Time frame: At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.
Positive Predictive Value (PPV)
Time frame: At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.
Negative Predictive Value (NPV)
Time frame: At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.
Area Under the Curve (AUC)
Time frame: At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.
Incidence of adverse events
Time frame: At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.