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Updated: May 3, 2026
Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation
Published on: August 25, 2022
Phase I study demonstrates safety and tolerability of radiofrequency ablation (RFA) of the anal mucosa
A George Smulian1, Diana M Moore2, Jaime C Robertson1
1Cincinnati VA Medical Center, Cincinnati, Ohio Infectious Diseases, University of Cincinnati, Cincinnati, Ohio.
Background:
Anal carcinoma is increasing in high-risk populations. Dysplasia is often distributed throughout the anal mucosa, and focal ablative techniques have high rates of recurrence.
Methods:
With the goal of eradicating dysplasia from the entire anal mucosa, we conducted a phase I dose-ranging study to determine the safety and tolerability of radiofrequency ablation (RFA). HIV-infected individuals with high-grade anal intraepithelial neoplasia underwent RFA of the anal mucosa. Patient-reported procedural and postprocedural symptoms were recorded, and mucosal healing was visually assessed.
Results:
Four groups of 3 subjects each were treated with incrementally increasing numbers of RF pulses (1-3) applied to a single area of anal mucosa. Two or three doses of 12 J/cm2 were found to have acceptable patient tolerance and healing of the mucosa within 4 weeks of ablation. Using these doses, 2 groups underwent ablation of 180° of contiguous mucosa. Subjects experienced a loss of 1 to 3 days of daily activities of living, 7 to 14 days of postprocedure symptoms, and mucosal healing within 4 weeks. One subject in the first treatment group had the procedure aborted due to severe procedural pain.
Conclusions:
The study provides evidence of the safety and tolerability of anal RFA of 180° of contiguous mucosa in a single procedure and will allow future RFA efficacy studies in the treatment of anal dysplasia.
