Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7080, USA.
Gastroenterology. 2011 Aug;141(2):460-8. doi: 10.1053/j.gastro.2011.04.061. Epub 2011 May 6.
BACKGROUND & AIMS: Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE.
We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events.
After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). Kaplan-Meier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years).
In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years.
射频消融(RFA)可消除异型增生和肠上皮化生,降低异型增生 Barrett 食管(BE)患者的食管腺癌发病率。我们评估了 RFA 治疗异型增生 BE 的长期消除率、新鳞状上皮的耐久性、疾病进展和安全性。
我们对 127 例异型增生 BE 患者进行了一项随机试验;交叉后,119 例患者接受了 RFA 治疗。中位随访时间为 3.05 年;对于 2 年内肠上皮化生完全消除的患者,研究延长至 5 年。结局包括 2 年和 3 年后的异型增生或肠上皮化生消除率、反应的耐久性、疾病进展和不良事件。
2 年后,106 例患者中有 101 例(95%)完全消除了所有异型增生,106 例中有 99 例(93%)消除了肠上皮化生。2 年后,初始低级别异型增生的患者中,52 例(98%)所有异型增生均消除,52 例(98%)肠上皮化生均消除;初始高级别异型增生的患者中,54 例(93%)所有异型增生均消除,54 例(89%)肠上皮化生均消除。3 年后,56 例患者中有 55 例(98%)异型增生消除,56 例中有 51 例(91%)肠上皮化生消除。Kaplan-Meier 分析显示,超过 85%的患者异型增生持续消除,超过 75%的患者肠上皮化生持续消除,无需维持 RFA。119 例患者中有 4 例(3.4%)发生严重不良事件;狭窄发生率为 7.6%。食管腺癌发生率为每 181 例患者年 1 例(0.55%/患者年);无癌症相关发病率或死亡率。任何肿瘤进展的年发生率为每 73 例患者年 1 例(1.37%/患者年)。
在异型增生 BE 患者中,RFA 治疗具有可接受的安全性,且反应持久,3 年内疾病进展率较低。