Electrocautery ablation therapy for anal intraepithelial carcinoma with high-resolution anoscopy.

Objective: This study investigated the efficacy and safety of electrocautery ablation for high-grade squamous intraepithelial lesions (HSILs) in men who have sex with men (MSM) including people with human immunodeficiency virus, using comprehensive biopsy with high-resolution anoscopy (HRA).

Methods: This single-arm, open-label pilot study included 20 MSM with HSIL who were treated with electrocautery ablation. The participants were recruited from the National Center for Global Health and Medicine and followed up using HRA with a comprehensive biopsy approach at 3- and 6-months post-ablation. A comprehensive biopsy was defined as at least 1 biopsy taken from each of the 6 segments of the anal canal regardless of any abnormal findings. The primary endpoint was the local HSIL cure rate at 6 months. Secondary endpoints included the total cure rate, recurrence rates, and adverse events.

Results: The median age of the 20 participants was 45 years, and 90 % were HIV-positive. The local cure rates were 40 % at 3 months and 50 % at 6 months. The total cure rates were 35 % and 40 % at 3 and 6 months, respectively. Ectopic recurrence occurred in 27.8 % of the participants. Most adverse events were mild and self-limiting.

Conclusion: Electrocautery ablation was a moderately effective and safe treatment for HSIL among MSM in Japan. However, the recurrence rates were high, indicating that conducting biopsies on normal-appearing lesions did not sufficiently prevent ectopic recurrence. Further research with larger sample sizes and longer follow-up periods is warranted to improve outcomes. This trial was registered in the Japan Registry of Clinical Trials: Clinical Trial Plan Number: jRCTs032210649.