Diagnostic Strategies After Negative Colposcopy in High-Grade Cervical Cytology: A Multicenter Randomized Trial

Area of Science:

• Gynecology
• Cervical Cancer Screening
• Diagnostic Accuracy

Background:

• Colposcopy is crucial for managing abnormal cervical cytology.
• Negative colposcopy in high-grade cytology cases presents a diagnostic challenge.
• Accurate detection of high-grade squamous intraepithelial lesions or worse (HSIL+) is essential.

Purpose of the Study:

• To compare diagnostic strategies for HSIL+ in women with high-grade cytology and negative colposcopy.
• To evaluate the role of sequential HPV testing, liquid-based cytology (LBC), and endocervical sampling.
• To assess improvements in diagnostic safety and accuracy.

Main Methods:

• Multicenter randomized clinical trial involving 257 women with ASC-H or worse cytology and negative colposcopy.
• Sequential HPV testing and LBC were performed.
• Randomization to endocervical brushing (EB) or endocervical curettage (ECC).
• Histopathology served as the reference standard.

Main Results:

• HPV testing demonstrated high sensitivity (94.3%) and negative predictive value (98.6%).
• LBC showed higher specificity (84.9%) and accuracy (84.1%).
• Combining HPV and LBC (AND rule) yielded 91.7% specificity and 77.1% sensitivity.
• Adding EB (MAJORITY rule) increased sensitivity to 100% but decreased specificity to 82.3%.

Conclusions:

• HPV testing followed by LBC offers a balanced diagnostic strategy for HSIL+ detection.
• Endocervical brushing may enhance sensitivity for HSIL+ in select high-risk individuals.
• These strategies improve diagnostic safety after negative colposcopy.