Laser Ablation in the Treatment of High-grade Cervical Lesions

High-Grade Squamous Intraepithelial Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06333743
• Other study ID #: ZhuLan
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: Peking Union Medical College Hospital
• Contact: Lan Zhu, MD
• Phone: 86-010-69156874
• Email: zhulan[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 308
• Est. completion date: May 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma, Squamous Cell
• High-Grade Squamous Intraepithelial Lesions
• Squamous Intraepithelial Lesions of the Cervix

Intervention

Procedure:
• laser ablation
Research has confirmed that laser ablation treatment of cervical HSIL is effective and feasible.
• LEEP or Conization
The most common treatment for HSIL is LEEP or conization of the cervical lesion, but there are several perinatal complications involved in this surgery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Obstetrics & Gynecology Hospital of Fudan University

References & Publications (9)

Fallani MG, Penna C, Fambrini M, Marchionni M. Laser CO2 vaporization for high-grade cervical intraepithelial neoplasia: a long-term follow-up series. Gynecol Oncol. 2003 Oct;91(1):130-3. doi: 10.1016/s0090-8258(03)00440-2. — View Citation

Inaba K, Nagasaka K, Kawana K, Arimoto T, Matsumoto Y, Tsuruga T, Mori-Uchino M, Miura S, Sone K, Oda K, Nakagawa S, Yano T, Kozuma S, Fujii T. High-risk human papillomavirus correlates with recurrence after laser ablation for treatment of patients with c — View Citation

Kodama K, Yahata H, Okugawa K, Tomonobe H, Yasutake N, Yoshida S, Yagi H, Yasunaga M, Ohgami T, Onoyama I, Asanoma K, Hori E, Shimokawa M, Kato K. Prognostic outcomes and risk factors for recurrence after laser vaporization for cervical intraepithelial ne — View Citation

Kyrgiou M, Koliopoulos G, Martin-Hirsch P, Arbyn M, Prendiville W, Paraskevaidis E. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis. Lancet. 2006 Feb 11;367(9509):489-98. doi: 10.1016/S0140-6736(06)68181-6. — View Citation

Mariya T, Nishikawa A, Sogawa K, Suzuki R, Saito M, Kawamata A, Shimizu A, Nihei T, Sonoda T, Saito T. Virological and cytological clearance in laser vaporization and conization for cervical intra-epithelial neoplasia grade 3. J Obstet Gynaecol Res. 2016 — View Citation

Perkins RB, Guido RS, Castle PE, Chelmow D, Einstein MH, Garcia F, Huh WK, Kim JJ, Moscicki AB, Nayar R, Saraiya M, Sawaya GF, Wentzensen N, Schiffman M; 2019 ASCCP Risk-Based Management Consensus Guidelines Committee. 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors. J Low Genit Tract Dis. 2020 Apr;24(2):102-131. doi: 10.1097/LGT.0000000000000525. No abstract available. Erratum In: J Low Genit Tract Dis. 2020 Oct;24(4):427. — View Citation

Sadler L, Saftlas A, Wang W, Exeter M, Whittaker J, McCowan L. Treatment for cervical intraepithelial neoplasia and risk of preterm delivery. JAMA. 2004 May 5;291(17):2100-6. doi: 10.1001/jama.291.17.2100. — View Citation

Yoon BS, Seong SJ, Song T, Kim ML, Kim MK. Risk factors for treatment failure of CO2 laser vaporization in cervical intraepithelial neoplasia 2. Arch Gynecol Obstet. 2014 Jul;290(1):115-9. doi: 10.1007/s00404-014-3148-1. Epub 2014 Jan 24. — View Citation

Zhang L, Sauvaget C, Mosquera I, Basu P. Efficacy, acceptability and safety of ablative versus excisional procedure in the treatment of histologically confirmed CIN2/3: A systematic review. BJOG. 2023 Jan;130(2):153-161. doi: 10.1111/1471-0528.17251. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of HSIL recurrence	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.	12 months after treatment
Secondary	the satisfaction with the treatment	after the treatment, patients will fill in a questionnaire to describe their degree of satisfaction with the treatment	8 weeks and 12 months after treatment
Secondary	the length of the cervix	the length of the cervix will be measured by B-ultrasound	8 weeks and 12 months after treatment
Secondary	Psychological state change related to the treatment	State-Trait Anxiety Inventory,STAI-Form Y will be used to measure the patients' psychological state after treatment.	8 weeks and 12 months after treatment

External Links

•   WHO guidelines for the use of thermal ablation for cervical pre-cancer lesions