Laser Ablation in the Treatment of High-grade Cervical Lesions

March 20, 2024 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

308

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laser ablation treatment
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.
Procedure: laser ablation
Research has confirmed that laser ablation treatment of cervical HSIL is effective and feasible.
Active Comparator: LEEP or conization treatment
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of HSIL recurrence
Time Frame: 12 months after treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the satisfaction with the treatment
Time Frame: 8 weeks and 12 months after 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
the length of the cervix
Time Frame: 8 weeks and 12 months after treatment
the length of the cervix will be measured by B-ultrasound
8 weeks and 12 months after treatment
Psychological state change related to the treatment
Time Frame: 8 weeks and 12 months after 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Obstetrics & Gynecology Hospital of Fudan University

Investigators

  • Principal Investigator: Lan Zhu, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhuLan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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