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射频消融治疗 Barrett 食管:来自多中心社区实践注册中心的 429 例患者的结果。

Radiofrequency ablation of Barrett's esophagus: outcomes of 429 patients from a multicenter community practice registry.

机构信息

The Center for GI Health, Cancer Prevention, Management and Nutritional Therapy, A Division of Atlanta Gastroenterology Associates, LLC, Atlanta, Atlanta, Georgia, USA.

出版信息

Endoscopy. 2010 Apr;42(4):272-8. doi: 10.1055/s-0029-1243883. Epub 2010 Feb 9.

Abstract

BACKGROUND AND STUDY AIMS

The use of radiofrequency ablation (RFA) for complete eradication of Barrett's esophagus has shown promise in trials conducted at predominantly tertiary academic centers; however less is known regarding outcomes in the community. We evaluated the safety and efficacy of RFA for Barrett's esophagus delivered in a community practice setting.

PATIENTS AND METHODS

This was a multicenter registry conducted in community-based gastroenterology practices. Patients had confirmed intestinal metaplasia with or without dysplasia on biopsy of a Barrett's esophagus. Intervention was step-wise RFA with follow-up esophageal biopsies. Endpoints were histology-based; complete response was defined as all biopsies at most recent endoscopy negative for intestinal metaplasia (CR-IM) or dysplasia (CR-D). Three cohorts were reported: 1) safety cohort, all patients; 2) efficacy cohort A, patients with at least one biopsy session after initial treatment; 3) efficacy cohort B, patients with at least one biopsy session > or = 1 year after initial treatment.

RESULTS

The safety cohort included 429 patients (71 % men, median age 59 years, median Barrett's segment 3.0 cm). There were no serious adverse events (bleeding, perforation, death), and a stricture occurred after 1.1 % of cases (2.1 % of patients). In efficacy cohort A (n = 338), CR-IM and CR-D were achieved in 72 % and 89 % of patients, respectively (median follow-up 9 months). In efficacy cohort B (n = 137), CR-IM and CR-D were achieved in 77 % and 100 % of patients, respectively (median follow-up 20 months).

CONCLUSIONS

In this multicenter registry conducted at four community-based practices, the observed safety and efficacy outcomes associated with RFA for Barrett's esophagus are comparable to those previously reported in multicenter trials from predominantly tertiary academic centers.

摘要

背景与研究目的

射频消融(RFA)在主要的三级学术中心进行的试验中显示出有望彻底根除巴雷特食管,但在社区中,其结果知之甚少。我们评估了 RFA 在社区实践环境下治疗巴雷特食管的安全性和有效性。

患者和方法

这是一项在社区为基础的胃肠病学实践中进行的多中心登记研究。患者的巴雷特食管活检证实存在肠上皮化生,伴或不伴异型增生。干预措施是逐步进行 RFA 并随访食管活检。终点为基于组织学的;完全缓解定义为最近一次内镜检查时所有活检均无肠上皮化生(CR-IM)或异型增生(CR-D)。报告了三个队列:1)安全性队列,所有患者;2)疗效队列 A,初始治疗后至少有一次活检的患者;3)疗效队列 B,初始治疗后至少有一次活检> = 1 年的患者。

结果

安全性队列包括 429 例患者(71%为男性,中位年龄 59 岁,中位 Barrett 段 3.0cm)。无严重不良事件(出血、穿孔、死亡),1.1%的病例发生狭窄(2.1%的患者)。在疗效队列 A(n=338)中,CR-IM 和 CR-D 的达成率分别为 72%和 89%(中位随访 9 个月)。在疗效队列 B(n=137)中,CR-IM 和 CR-D 的达成率分别为 77%和 100%(中位随访 20 个月)。

结论

在这项由四个社区实践进行的多中心登记研究中,观察到的与 RFA 治疗巴雷特食管相关的安全性和有效性结果与以前主要在三级学术中心进行的多中心试验中报告的结果相当。

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