Author:
Mitani Takeji,Kukimoto Iwao,Tsukamoto Tetsuya,Nomura Hiroyuki,Fujii Takuma
Abstract
AbstractApproximately 500,000 women are diagnosed with cervical cancer annually, with high-grade cervical intraepithelial neoplasia (CIN) estimated to be 20 times higher. The diathermy ablation is an inexpensive minimally invasive surgeries for CIN. However, little is known about the treatment outcomes. A prospective clinical trial was therefore conducted to evaluate ablation outcomes based on detailed colposcopy findings, cytology, and biopsy results over a two-year period. We enrolled CIN2 (n = 32) and CIN3 (n = 7) patients. Eligibility criteria included: aged between 29 and 49 (median: 36, mean: 36.3), visible transformation zone with high-grade lesions not entirely occupying the cervix, and histologically diagnosed with CIN2 or CIN3. Cytology and HPV genotyping were performed, and colposcopic findings were evaluated. Colposcopy-guided diathermy ablation was conducted by a certified gynecologic oncologist. The incidence of recurrent or residual disease was 5.1% (2/39, 95% confidence interval: − 0.02 to 0.12). The prevalence of HPV infection at 12 months decreased after surgery, as 67.6% (23/34, 0.52–0.83) of patients were HPV-negative. No severe adverse events were reported, while there were five pregnancies with full-term deliveries. The promising outcome was possibly due to selection of rigorous surgical indication and skilled surgical techniques. The study highlights the importance of experienced and skilled colposcopists.TrialRegistry This study was registered in the clinical trial registration system of the University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR ID: UMIN000024483). Open for the trial to the public through the website: 01/11/2016. First registration of the patient: 30/01/2017.
Funder
Fujita Health University Research Grant-in-Aid
Publisher
Springer Science and Business Media LLC
Reference30 articles.
1. Prendiville, W. & Sankaranarayanan, R. The role of colposcopy in cervical precancer Colposcopy and Treatment of Cervical Precancer, 1–12 (International Agency for Research on Cancer, 2017).
2. Ghaem-Maghami, S., Sagi, S., Majeed, G. & Soutter, W. P. Incomplete excision of cervical intraepithelial neoplasia and risk of treatment failure: A meta-analysis. Lancet Oncol. 8, 985–993 (2007).
3. Pinder, L. F. et al. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: Pilot phase of a randomised controlled trial. Lancet Oncol. 21, 175–184 (2020).
4. Kyrgiou, M. et al. Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: Systematic review and meta-analysis. Lancet. 367, 489–498 (2006).
5. Soler, M., Masch, R., Saidu, R. & Cremer, M. Thermal ablation treatment for cervical precancer (cervical intraepithelial neoplasia grade 2 or higher [CIN2+]). Methods Mol. Biol. 2394, 867–882 (2022).