Clinical trial NCT06333743: Laser Ablation in the Treatment of High-grade Cervical Lesions
Official title: Efficacy, Acceptability, and Safety of Laser Ablation in the Treatment of High-grade Cervical Lesions: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High-Grade Squamous Intraepithelial Lesions
Keywords: HSIL
laser ablation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Obstetrics & Gynecology Hospital of Fudan University
First posted: 2024-03-27
Enrollment: 308
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervical laser ablation is an effective, minimally invasive treatment with a low incidence of perinatal complications and minimal impact on fertility. Research has confirmed that laser ablation treatment of cervical HSIL (including CIN2 and CIN3) is effective and feasible and is useful for young CIN3 patients who wish to get pregnant in the future. There have been no randomized clinical trials of laser ablation therapy for cervical HSIL in Chinese women. This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL.

Detailed description: 1. Background This study focuses on the application of laser ablation in the treatment of cervical HSIL, explores the efficacy, feasibility, and safety of laser ablation in the treatment of cervical HSIL, and strives to promote the reasonable application of laser ablation in the treatment of cervical HSIL.
2. Research objects Young patients with cervical HSIL underwent colposcopic evaluation, completed cervical biopsy, and were pathologically confirmed to be eligible for ablation.
3. Methods 3.1 Sample size This study was a randomized controlled trial with parallel design. HSIL recurrence rate was the primary endpoint. According to previous literature reports, it is estimated that the recurrence rate of HSIL in the laser treatment group is 15%. The recurrence rate of HSIL in the resection group was 5%. Let α=0.05 (both sides), hold =0.80. Using PASS 11 software, the sample size of both groups was 138 cases. Assuming that the loss of follow-up rate of the study subjects was 10%, the sample size of each group was 138÷0.9=154 cases. Therefore, 308 patients were intended to be included in the study.

   3.2 Statistical methods SPSS 24.0 software will be used for statistical analysis of all data. Measurement data with normal distribution will be described by mean ± standard deviation. Independent sample t-test or rank sum test will be used for inter-group comparison, and paired sample t-test will be used for intra-group comparison before and after treatment. Counting data will be expressed as examples or percentages (%), and the Chi-square test will be used for comparison between groups. The Kaplan-Meier method will be used to calculate the recurrence rate, and the rank sum test will be used to evaluate the difference between the two groups. Cox regression model will be used to analyze the factors influencing prognosis. P \< 0.05 will be considered statistically significant.
4. Results The primary endpoint is the HSIL recurrence rate at 12 months after treatment.

Other subjects were secondary study endpoints shown as follows:

Intraoperative and postoperative complications and side effects, including bleeding, pain, infection, cervical secretions, and healing; Psychological state change; Satisfaction; Cervical length; Recurrence rate; Fees

Eligibility criteria: Inclusion Criteria:

1. \< 40-year-old
2. Cervical HSIL confirmed by colposcopic biopsy pathology
3. Cervical transformation zone type 1 or 2
4. The lesion is completely visible and does not extend into the cervical canal, and the lesion area is less than 50% of the cervical surface area
5. Colposcopic evaluation ruled out invasive cancer
6. Voluntary participation in the study with full and informed consent

Exclusion Criteria:

1. Cervical transformation zone type 3
2. Glandular epithelial lesions
3. Lesions greater than 50% of cervical surface area, or with vaginal and vulvar intraepithelial lesions
4. The upper margin of the lesion was not visible or extended into the cervical canal
5. Cervical tube sampling was diagnosed with CIN2+ or CIN that could not be graded
6. Cervical biopsy is not sufficient to confirm a tissue diagnosis
7. Suspected invasive cancer
8. History of cervical surgery
9. Pregnancy or planning a pregnancy during study participation
10. Autoimmune or immune deficiency diseases
11. Long-term use of immunosuppressive drugs

Primary outcomes:
measure: the rate of HSIL recurrence
timeFrame: 12 months after treatment
Secondary outcomes:
measure: the satisfaction with the treatment
timeFrame: 8 weeks and 12 months after treatment
measure: the length of the cervix
timeFrame: 8 weeks and 12 months after treatment
measure: Psychological state change related to the treatment
timeFrame: 8 weeks and 12 months after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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