About this trial
This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.
Eligibility criteria
Qualifiers
Female, 25-60 years, understands study procedures and consents to participate;
Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
Provides written informed consent.
Disqualifiers
Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
Undiagnosed vaginal bleeding;
Trial design
Treatments tested in this trial
- ALA-PDT
- LEEP surgery
Treatment groups
Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborator
First People's Hospital of Hangzhou
Collaborator
First Affiliated Hospital of Ningbo University
Collaborator
Shaoxing People's Hospital
Collaborator
Linping First People's Hospital
Collaborator