Goldstone Robert N, Hasan Shirin R, Drury Steven, Darragh Teresa M, van Zante Annemieke, Goldstone Stephen E
Massachusetts General Hospital, Boston, MA, USA.
Medtronic, Sunnyvale, CA, USA.
Int J Colorectal Dis. 2017 Mar;32(3):357-365. doi: 10.1007/s00384-016-2679-2. Epub 2016 Oct 21.
Radiofrequency ablation (RFA) effectively treats esophageal high-grade dysplasia, but its efficacy in treating anal canal high-grade squamous intraepithelial lesions (HSILs) is unsubstantiated. This prospective study assessed the safety and efficacy of applying hemi-circumferential RFA to anal canal HSIL.
Twenty-one HIV-negative participants with HSIL occupying ≤ half the anal canal circumference were treated with hemi-circumferential anal canal RFA. Participants were assessed every 3 months for 12 months with high-resolution anoscopy; recurrence in the treatment zone was re-treated with focal RFA.
Twenty-one participants with a mean of 1.7 lesions (range 1-4) enrolled and completed the trial. Six (29 %) participants had recurrent HSIL within the treated hemi-circumference within 1 year. Four participants (19 %) had persistence of an index lesion at 3 months. One (2.9 %) index HSIL persisted again at 12 months. No participants had more than two RFA treatments. KM curve-predicted HSIL-free survival within the treatment zone at 1 year was 76 % (95 % CI 52-89 %). Comparing the first 7 and last 14 participants, the predicted 1-year HSIL-free survivals are 43 % (95 % CI 10-73 %) and 93 % (95 % CI 59-99 %), respectively (p = 0.008), suggesting a learning curve with the treating physician. Multivariable analysis showed decreased recurrence in the last 14 participants (HR 0.02; 95 % CI 0.001-0.63) while increasing BMI increased recurrence (HR 1.43, 95 % CI 1.01-2.01). No participants had device or procedure-related serious adverse events, anal stricture, or heavy bleeding.
Hemi-circumferential RFA yielded a high rate of anal HSIL eradication in HIV-negative patients at 1 year with minimal adverse events. Lesion persistence was probably related to incomplete initial ablation.
射频消融（RFA）可有效治疗食管高级别发育异常，但其治疗肛管高级别鳞状上皮内病变（HSIL）的疗效尚无确凿证据。本前瞻性研究评估了半环周RFA治疗肛管HSIL的安全性和疗效。
21名HIV阴性、HSIL累及肛管周径≤一半的参与者接受了半环周肛管RFA治疗。在12个月内，每3个月用高分辨率肛门镜对参与者进行评估；治疗区域复发者用局部RFA再次治疗。
21名平均有1.7个病灶（范围1 - 4个）的参与者入组并完成试验。6名（29%）参与者在1年内治疗的半周内出现HSIL复发。4名（19%）参与者在3个月时存在原发病灶持续存在。1名（2.9%）原发病灶HSIL在12个月时再次持续存在。没有参与者接受超过两次RFA治疗。Kaplan-Meier曲线预测治疗区域1年无HSIL生存率为76%（95%CI 52 - 89%）。比较前7名和后14名参与者，预测的1年无HSIL生存率分别为43%（95%CI 10 - 73%）和93%（95%CI 59 - 99%）（p = 0.008），提示存在治疗医生的学习曲线。多变量分析显示后14名参与者复发率降低（HR 0.02；95%CI 0.001 - 0.63），而BMI增加会增加复发率（HR 1.43，95%CI 1.01 - 2.01）。没有参与者发生与设备或操作相关的严重不良事件、肛门狭窄或大出血。
半环周RFA在1年内对HIV阴性患者肛管HSIL的根除率高，不良事件极少。病灶持续存在可能与初始消融不完全有关。
