A Prospective, Dual-Center Trial of Circumferential Radiofrequency Ablation of Anal High-Grade Squamous Intraepithelial Lesions Demonstrate Improved Long-term Efficacy Over Historical Controls of Targeted Ablation.

Abstract

Targeted ablation of anal canal high-grade dysplasia results in high recurrence over time. Circumferential radiofrequency ablation might decrease recurrence.To determine the safety and efficacy of circumferential radiofrequency ablation for anal high-grade dysplasia.A dual-center prospective trial of circumferential radiofrequency ablation with 1 year follow-up with longer follow-up data abstracted from medical records of study patients returning post trial for surveillance. Ten participants from the identically conducted pilot circumferential radiofrequency ablation trial were combined to improve sample size for longer-term analysis.The study included 51 patients undergoing circumferential radiofrequency ablation for anal canal high-grade dysplasia.Three surgeons at 2 sites.Circumferential radiofrequency ablation of anal canal high-grade dysplasia and targeted radiofrequency ablation of recurrence.The primary measures were circumferential radiofrequency ablation efficacy and associated morbidity.Fifty-one participants underwent circumferential radiofrequency ablation but 48 returned for ≥1 post-procedure high-resolution anoscopy and were evaluable. Participants mean age was 43 years, mostly male (94%), 33% living with HIV and 58% had ≥3 high-grade dysplasias treated. Sixty percent had no recurrence while 19%, 15%, and 6% had 1, 2 or 3 recurrences. Most recurrence (66%) developed within the first 6 months. Kaplan-Meier probability of recurrence combining both series was 19% at 3 months, 30% at 6 months, and approximately 40% after 6 months out to 30 months. Most common morbidities were pain (85.4%) lasting a median of 21 (range, 4-91) days and bleeding (91%) lasting a median of 21 (range 5-87) days. Of those with pain and bleeding 65% and 85%, respectively, described it as mild. No patients developed fistulae, stricture or incontinence. No serious adverse events related to circumferential radiofrequency ablation occurred. Having a prior recurrence was the only significant predictor of a subsequent recurrence (HR 28.53) for recurrence at 9 months or prior.Enrollment ended prematurely and 10 participants from the pilot study were combined to increase sample size. Longer-term follow-up was collected retrospectively.Circumferential radiofrequency ablation has improved efficacy over targeted ablation but with increased pain and bleeding. See Video Abstract at http://links.lww.com/DCR/B973.