high-grade squamous intraepithelial lesions of the cervix
Conditions
Interventions
5-ALA Group:Photodynamic therapy
Control group:LEEP surgery
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Women over the age of 18 have full civil capacity and good compliance. (2) During the screening period, the transformation area was completely visible (type 1 transitional area) under colposcopy, and HSIL was found in the cervical histopathology within 3 months. (3) Within the past 3 months, the HR-HPV test was positive (i.e. HPV typing 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68 positive). (4) Pregnancy test is negative; No pregnancy plan during treatment; No sexual activity or strict contraceptive measures during the period from the last menstrual period to the beginning of treatment; Agree to use condoms for contact contraception during treatment. (5) Volunteer to participate in this treatment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Atypical glandular cells (AGC), adenocarcinoma in situ (AIS), or malignant cells were found in cytology/histology, or cancerous lesions and cancerous infiltration were suspected. (2) Infiltrating cancer cannot be ruled out through colposcopy examination, or the affected tissue extends to the vaginal wall. (3) Severe gynecological inflammation in the pelvic cavity, cervix, or other areas was found in other clinical/laboratory examinations. (4) Individuals with unexplained abnormal vaginal bleeding symptoms within 3 months without diagnosis. (5) Currently in the stage of allergic disease onset; Known or suspected presence of porphyria; Individuals with a history of allergies to photosensitizers or their analogues used in treatment. (6) Previously had severe cardiovascular, cerebrovascular, neurological, endocrine, hematopoietic, or psychiatric diseases, but currently not fully recovered; Immune dysfunction, long-term use of corticosteroids or immunosuppressive drugs; A history of malignant tumors within the past 5 years. (7) Abnormal liver and kidney function (ALT or AST exceeding the upper limit of the reference value range by three times).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation; | — |
Countries
China
Contacts
Public ContactJing Chen
Shanghai Sixth People's Hospital
Outcome results
None listed