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采用 HALO90 设备行局灶性射频消融的简化方案:在发育异常性 Barrett 食管患者中的短期疗效和安全性。

Simplified protocol for focal radiofrequency ablation using the HALO90 device: short-term efficacy and safety in patients with dysplastic Barrett's esophagus.

机构信息

Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands.

Department of Gastroenterology and Hepatology, Academic Medical Center Amsterdam, The Netherlands.

出版信息

Endoscopy. 2015 Jul;47(7):592-7. doi: 10.1055/s-0034-1391436. Epub 2015 Feb 12.

DOI:10.1055/s-0034-1391436
PMID:25675174
Abstract

BACKGROUND AND STUDY AIMS

The standard protocol for focal radiofrequency ablation (RFA) of Barrett's esophagus comprises two applications of radiofrequency energy, cleaning of the ablated areas and catheter, and two further applications (2 × 15 J/cm(2) - cleaning - 2 × 15 J/cm(2)). A simplified protocol (3 × 15 J/cm(2), no cleaning) proved noninferior to standard protocol for individual islands of Barrett's esophagus, but may be associated with higher stenosis rates when applied circumferentially and sequentially over time. We evaluated the efficacy and safety of the above mentioned simplified protocol.

PATIENTS AND METHODS

Barrett's esophagus patients undergoing focal RFA using the simplified protocol in four tertiary referral centers were retrospectively included. During each focal ablation, the gastroesophageal junction (GEJ) was ablated circumferentially in addition to Barrett's esophagus islands or tongues. Sessions continued at 8 to 12-week intervals until complete resolution of Barrett's esophagus. Primary outcome parameters comprised complete remission of dysplasia and of intestinal metaplasia, and stenosis requiring dilation.

RESULTS

83 patients with dysplastic Barrett's esophagus (median Prague classification C1M3) were enrolled; 66/83 (80 %) had endoscopic resection of a visible lesion before RFA. Intention-to-treat analysis showed complete remission of dysplasia in 78/83 (94 %) and of intestinal metaplasia in 72/83 (87 %). Stenosis requiring dilation developed in 9/83 (11 %), necessitating a median 2 dilation sessions (range 1 - 9), with ≥ 8 sessions in three patients.

CONCLUSION

A treatment algorithm incorporating the simplified protocol of 3 × 15 J/cm(2), with no cleaning, for all focal RFA sessions, appears effective. The associated number and severity of stenoses, however, raises safety concerns.

摘要

背景和研究目的

巴雷特食管的标准焦点射频消融(RFA)方案包括两次射频能量应用、消融区域和导管的清洁以及另外两次应用(2×15 J/cm²-清洁-2×15 J/cm²)。简化方案(3×15 J/cm²,无需清洁)已被证明在单个巴雷特食管岛中不劣于标准方案,但随着时间的推移,在圆周和顺序应用时可能与更高的狭窄率相关。我们评估了上述简化方案的疗效和安全性。

患者和方法

回顾性纳入在四个三级转诊中心使用简化方案进行焦点 RFA 的巴雷特食管患者。在每次焦点消融中,除了巴雷特食管岛或舌外,还对胃食管交界处(GEJ)进行圆周消融。每次消融间隔 8 至 12 周,直到巴雷特食管完全消退。主要结局参数包括异型增生和肠化生的完全缓解以及需要扩张的狭窄。

结果

83 例异型增生性巴雷特食管患者(中位数布拉格分类 C1M3)入组;66/83(80%)在 RFA 前有可见病变的内镜切除术。意向治疗分析显示,78/83(94%)完全缓解异型增生,72/83(87%)完全缓解肠化生。9/83(11%)出现需要扩张的狭窄,需要中位数 2 次扩张(范围 1-9),3 例患者需要≥8 次扩张。

结论

对于所有焦点 RFA 治疗方案,纳入简化方案(3×15 J/cm²,无需清洁)的治疗算法似乎有效。然而,相关的狭窄数量和严重程度引起了安全方面的担忧。

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