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Trial Title:
Laser Ablation in the Treatment of High-grade Cervical Lesions
NCT ID:
NCT06333743
Condition:
High-Grade Squamous Intraepithelial Lesions
Conditions: Official terms:
Squamous Intraepithelial Lesions of the Cervix
Carcinoma, Squamous Cell
Carcinoma in Situ
Conditions: Keywords:
HSIL
laser ablation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
laser ablation
Description:
Research has confirmed that laser ablation treatment of cervical HSIL is effective and
feasible.
Arm group label:
laser ablation treatment
Intervention type:
Procedure
Intervention name:
LEEP or Conization
Description:
The most common treatment for HSIL is LEEP or conization of the cervical lesion, but
there are several perinatal complications involved in this surgery.
Arm group label:
LEEP or conization treatment
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
Criteria for 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
Gender:
Female
Minimum age:
N/A
Maximum age:
40 Years
Healthy volunteers:
No
Start date:
May 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Obstetrics & Gynecology Hospital of Fudan University
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06333743
http://www.ncbi.nlm.nih.gov/books/NBK549182/