Laser Ablation in the Treatment of High-grade Cervical Lesions

NCT06333743 | Not Yet Recruiting

• 1 other identifier: ZhuLan
• Study Type: interventional
• Target: 308
• Locations: 0 countries
• Sites: N/A

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.

Conditions

High-Grade Squamous Intraepithelial Lesions

Keywords

HSIL; laser ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the satisfaction with the treatment

  8 weeks and 12 months after treatment

• the length of the cervix

  8 weeks and 12 months after treatment

• Psychological state change related to the treatment

  8 weeks and 12 months after treatment

Study Arms (2)

laser ablation treatment

EXPERIMENTAL

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

LEEP or conization treatment

ACTIVE COMPARATOR

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

Interventions

laser ablation PROCEDURE

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

laser ablation treatment

LEEP or Conization PROCEDURE

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 treatment

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \< 40-year-old
• Cervical HSIL confirmed by colposcopic biopsy pathology
• Cervical transformation zone type 1 or 2
• 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
• Colposcopic evaluation ruled out invasive cancer
• Voluntary participation in the study with full and informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Obstetrics & Gynecology Hospital of Fudan University: collaborator

Related Publications (9)

• 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.

  PMID: 32243307 BACKGROUND

• 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.

  PMID: 15126438 BACKGROUND

• 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.

  PMID: 16473126 BACKGROUND

• 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.

  PMID: 14529672 BACKGROUND

• 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 Dec;42(12):1808-1813. doi: 10.1111/jog.13113. Epub 2016 Aug 16.

  PMID: 27526956 RESULT

• 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 2022 Jul 4.

  PMID: 35689493 RESULT

• 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.

  PMID: 24458427 RESULT

• 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 neoplasia: a single-center retrospective study. Int J Clin Oncol. 2021 Apr;26(4):770-776. doi: 10.1007/s10147-020-01848-x. Epub 2021 Jan 4.

  PMID: 33394202 RESULT

• 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 cervical intraepithelial neoplasia 3: a long-term follow-up retrospective study. J Obstet Gynaecol Res. 2014 Feb;40(2):554-60. doi: 10.1111/jog.12196. Epub 2013 Oct 11.

  PMID: 24118526 RESULT

Related Links

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

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Interventions

Laser Therapy; Conization

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Investigative Techniques

Study Officials

• Lan Zhu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan Zhu, MD

CONTACT

86-010-69156874; zhulan@pumch.cn

Jinhui Wang, MD

CONTACT

wjhpumch@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 27, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share