Electrocautery ablation therapy for anal intraepithelial carcinoma: A study protocol

Area of Science:

• Oncology
• Gastroenterology
• Dermatology

Background:

• Anal cancer is linked to human papillomavirus.
• High-resolution anoscopy (HRA) and treatment of high-grade squamous intraepithelial lesions (HSIL) are standard for anal cancer.
• Electrocautery ablation is effective for anal intraepithelial neoplasia (AIN) grades 2/3, but relapse is a concern.

Purpose of the Study:

• To investigate the efficacy and safety of electrocautery ablation for anal intraepithelial neoplasia (AIN) grades 2/3.
• To assess the feasibility of electrocautery ablation in Japan where it is not widely available.

Main Methods:

• Pilot intervention study using high-frequency medical devices for electrocautery ablation.
• Inclusion of patients diagnosed with AIN grades 2/3.
• Follow-up at 3 and 6 months with HRA-guided sextant biopsy (≥6 biopsies) to assess recurrence and adverse events.

Main Results:

• The primary outcome is the recurrence rate at 6 months post-ablation.
• Secondary outcomes include adverse event and recurrence rates at 3 months.
• Data on the effectiveness and safety of electrocautery ablation for AIN grades 2/3 will be provided.

Conclusions:

• This pilot study will offer crucial data on the effectiveness and safety of electrocautery ablation for treating anal intraepithelial neoplasia (AIN) grades 2/3.
• Findings will guide clinical practice regarding this therapeutic option.