Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Squamous Intraepithelial Lesions of the Cervix

Carcinoma

Carcinoma, Squamous Cell

Carcinoma in Situ

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Cervical Intraepithelial Neoplasia

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Micronutrients

Anti-Infective Agents

Anesthetics

Mepivacaine

Iodine

Cadexomer iodine

Laser vaporization is performed using a carbon dioxide laser under colposcopy. All patients received 1% mepivacaine hydrochloride paracervix block. No general anesthesia was used. Before laser vaporization began, scaly columnar nodules were visible in all patients. The evaporation depth is 8-10mm, and the edge is 5mm from the abnormal discovery or transition area.

The cervix was stained with iodine solution and the diseased lesion was visualized. LEEP or conization was performed to a depth of approximately 1.5 cm to resect disease in the cervical canal.

Research has confirmed that laser ablation treatment of cervical HSIL is effective and feasible.

laser ablation

The most common treatment for HSIL is LEEP or conization of the cervical lesion, but there are several perinatal complications involved in this surgery.

LEEP or Conization

Lan Zhu, MD

Jinhui Wang, MD

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.

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

Laser Ablation in the Treatment of High-grade Cervical Lesions

Efficacy, Acceptability, and Safety of Laser Ablation in the Treatment of High-grade Cervical Lesions: a Randomized Clinical Trial

12 months after the treatment, TCT, HPV, colposcopy, and biopsy will be tested again. If the result of the biopsy is HSIL again, we will record it as HSIL recurrence.

after the treatment, patients will fill in a questionnaire to describe their degree of satisfaction with the treatment

the length of the cervix will be measured by B-ultrasound

State-Trait Anxiety Inventory，STAI-Form Y will be used to measure the patients' psychological state after treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Laser Ablation in the Treatment of High-grade Cervical Lesions	NCT06333743	High-Grade Squa...	laser ablation LEEP or Conizat...	- 40 Years	Peking Union Medical College Hospital
Laser Ablation in the Treatment of High-grade Cervical Lesions	NCT06333743	High-Grade Squa...	laser ablation LEEP or Conizat...	- 40 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for leep or conization