• Medicine · Dec 2022

    Electrocautery ablation therapy for anal intraepithelial carcinoma: A study protocol.

    • Naokatsu Ando, Daisuke Mizushima, Misao Takano, Hiroshi Kitamura, Daisuke Shiojiri, Takato Nakamoto, Takahiro Aoki, Koji Watanabe, Haruka Uemura, Hiroyuki Gatanaga, and Shinichi Oka.
    • AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
    • Medicine (Baltimore). 2022 Dec 23; 101 (51): e32297e32297.

    BackgroundAnal cancer is a human papillomavirus-related cancer. Screening with high-resolution anoscopy (HRA) and subsequent therapeutic intervention are increasingly recognized as the standard procedure for anal cancer. Generally, lesions suspected as being high-grade squamous intraepithelial lesions are biopsied and treated if they are grade 2 or 3 anal intraepithelial neoplasia (AIN). According to several studies, electrocautery ablation for grade 2 or 3 AIN is highly effective. However, relapse within and outside the targeted areas after the intervention is a clinical problem. In Japan, electrocautery ablation is not available at most facilities. Therefore, this study aims to investigate the efficacy and safety of electrocautery ablation.MethodsThis single-arm, open-label, pilot intervention study will investigate the efficacy and safety of electrocautery ablative therapy using high-frequency medical devices. Patients diagnosed with grade 2 or 3 AIN will be included and will receive ablation treatment. Then, they will be followed up at 3 and 6 months after the procedure for HRA-guided sextant biopsy. To reduce the possibility of missed lesions before and after the intervention, we will perform HRA-guided sextant biopsy routinely. In this study, a sextant biopsy is defined as at least 6 biopsies in all directions, regardless of abnormal findings under HRA. The primary outcome is the recurrence rate at 6 months, and the secondary outcomes are the adverse event and recurrence rates at 3 months.ConclusionThis pilot study will provide data on the effectiveness and safety of electrocautery ablation as a treatment for grade 2 or 3 AIN.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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