Electrocautery ablation of high-grade anal intraepithelial lesions: A protocol for a clinical trial

Background: Anal cancer is predominantly caused by the human papillomavirus. The use of high-resolution anoscopy (HRA) for screening, followed by appropriate therapeutic interventions, is progressively being acknowledged as a standardized procedure to manage anal cancer. Commonly, lesions identified as potentially high-grade squamous intraepithelial lesions undergo biopsy and receive treatment if classified as anal intraepithelial neoplasia (AIN) grade 2 or 3. Numerous studies have underscored the substantial efficacy of electrocautery ablation in treating grade 2 or 3 AIN. However, relapse within and outside the targeted areas after intervention is a clinical problem. Postintervention recurrence within and beyond the initial targeted areas presents a significant clinical challenge. Most healthcare facilities in Japan do not offer electrocautery ablation. An initial pilot study demonstrated the safety and efficacy of electrocautery ablation. Consequently, we aimed to scrutinize the effectiveness and safety profile of electrocautery ablation procedures using a larger sample size. Methods: This single-arm, open-label intervention trial aims to examine the efficacy and safety associated with electrocautery ablative treatments by utilizing high-frequency medical instruments. The cohort will comprise patients diagnosed with grade 2 or 3 AIN who will then undergo ablative treatments. Subsequent follow-ups will be scheduled at intervals of 6, 12, 24, and 36 months posttreatment, incorporating HRA-guided sextant biopsies to monitor disease progression. To minimize the chances of overlooking the lesions before and after the treatment phase, systematic HRA-guided sextant biopsies will be performed. Within the scope of this study, a sextant biopsy necessitates a minimum of 6 biopsy procedures in various directions, irrespective of any abnormalities detected during HRA inspections. The principal objective of this study is to ascertain the 12-month recurrence rate, with secondary objectives focusing on monitoring adverse events and recurrence rates at the 6-, 24-, and 36-month time points. Conclusion: This study aims to provide substantial data concerning the effectiveness and safety parameters of electrocautery ablation as a viable alternative treatment for patients with grade 2 or 3 AIN.