AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
Medicine (Baltimore). 2022 Dec 23;101(51):e32297. doi: 10.1097/MD.0000000000032297.
Anal 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.
This 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.
This pilot study will provide data on the effectiveness and safety of electrocautery ablation as a treatment for grade 2 or 3 AIN.
肛门癌是一种与人类乳头瘤病毒相关的癌症。使用高分辨率肛门镜（HRA）进行筛查以及随后的治疗干预越来越被认为是肛门癌的标准程序。通常，如果疑似高级别鳞状上皮内病变的病变是 2 级或 3 级肛门上皮内瘤变（AIN），则会进行活检并进行治疗。根据几项研究，对于 2 级或 3 级 AIN，电烙消融是非常有效的。然而，干预后在靶向区域内外的复发是一个临床问题。在日本，大多数医疗机构都无法进行电烙消融。因此，本研究旨在探讨电烙消融的疗效和安全性。
这项单臂、开放标签、先导性干预研究将调查使用高频医疗设备的电烙消融治疗的疗效和安全性。将纳入诊断为 2 级或 3 级 AIN 的患者，并接受消融治疗。然后，在治疗后 3 个月和 6 个月，对他们进行 HRA 引导的六分法活检随访。为了降低干预前后漏诊病变的可能性，我们将常规进行 HRA 引导的六分法活检。在本研究中，六分法活检定义为在所有方向上进行至少 6 次活检，无论 HRA 下是否有异常发现。主要结局是 6 个月时的复发率，次要结局是 3 个月时的不良事件和复发率。
这项先导性研究将提供关于电烙消融作为 2 级或 3 级 AIN 治疗方法的有效性和安全性的数据。
