Squamous Intraepithelial Lesions, Laser Burn
Conditions
Keywords
laser, Cervical intraepithelial neoplasia, Vaginal intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal intraepithelial neoplasia, Perianal intraepithelial neoplasia
Brief summary
Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.
Detailed description
Patients diagnosed with CIN, VaIN, VIN, AIN or PAIN are recruited with exclusion of suspicion of malignant tumors. We use multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and then follow up the patients for at least two years. By analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.
Interventions
PROCEDURElaser ablation
Laser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts.
Sponsors
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Had the history of sexual life. 2. Transferred to colposcopy examination and biopsy for abnormal screening of cervical cancer, contact bleeding of cervix, recurrent discomfort of vulva or abnormal signs of lower genital and anal tract. The pathology of biopsy indicate CIN, VaIN, VIN, AIN, or PaIN. 3. If CIN, the colposcopy manifests transformation zone-1 which means the lesion can totally be seen. However the consideration of fertility damage of resection overweighs the chance of suffering cancer. 4. The patients can accept multiple laser ablations and colposcopy examinations and follow-up at least 2 years.
Exclusion criteria
1. Patients who are suffering cancers of other systems and in treatment. 2. Patients suffering acute inflammation of lower genital and anal tracts. 3. The colposcopy and pathology examination suspect of cancer of lower genital and anal tract. 4. Patients suffering severe diseases such as insufficiency of liver and kidney function, diseases of blood system and other acute infections who will get heath harm from colposcopy and laser vaporization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological cure | up to at least two years | No squamous intraepithelial lesions found by pathological examinations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV clearance | Every six months after initial treatment for at least two years | The results of HPV tests are negative. |
Countries
China
Contacts
Primary ContactShuang Li, Doctor
Backup ContactDongli Kong, Doctor
Outcome results
None listed