RecruitingNot ApplicableNCT06052033

Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

The Effect of 5-aminolaevulinic Acid Photodynamic Therapy Versus C02 Laser in the Treatment of Persistent Cervical Low-grade Squamous Intraepithelial Lesions With High-risk HPV Infection:A Non-randomized Controlled Trail Study

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Enrollment

40 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

Aged 18-65 years old with a history of sexual activity.
Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6/E7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).
Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
No fundamental diseases of important organs.
Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
There has been no history of using other drugs related to HPV infection in the past 3 months.

Exclusion Criteria10

HR-HPV persistent infection.
A total hysterectomy has been performed.
Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.
Pregnant and lactating women.
Acute reproductive tract inflammation.
Diabetes patients with uncontrolled blood sugar.
Patients who do not receive full treatment and follow-up.
Those who fail to sign the informed consent form.

Interventions

PROCEDURECO2

CO2 laser treatment is a surgical procedure that employs a high-powered carbon dioxide laser beam to precisely ablate cervical lesions. The laser is applied with a depth of 7-10mm and a width of 3-5mm beyond the lesion area in a single session. This intervention aims to address persistent low-grade cervical lesions associated with high-risk HPV infection.