射频消融治疗 Barrett 食管相关肿瘤的 360 Express 导管：来自英国和爱尔兰的初步经验——初步结果。
Radiofrequency ablation for Barrett's oesophagus related neoplasia with the 360 Express catheter: initial experience from the United Kingdom and Ireland-preliminary results.
机构信息
University College London Hospital, London, UK.
Centre for Obesity Research, University College London, London, UK.
出版信息
Surg Endosc. 2022 Jan;36(1):598-606. doi: 10.1007/s00464-021-08325-0. Epub 2021 Feb 5.
BACKGROUND
Radio-frequency ablation (RFA) for Barrett's oesophagus (BE)-related neoplasia is currently used after endoscopic resection of visible neoplasia. The HALO 360 balloon has been used to ablate long segment BE. The Barrx™ 360 Express RFA self-sizing catheter ('RFA Express') may potentially allow quicker ablation times and improved treatment outcomes. The aim of this paper is to present real world data on the use of the 360 Express Device.
METHODS
Centres in the UK and Ireland submitted cases where the RFA Express was used. The primary outcome was regression of BE at 3 months. Secondary outcomes were the rate of symptomatic stricture formation and resolution of intestinal metaplasia (CR-IM) and dysplasia (CR-D) at End of Treatment (EoT).
RESULTS
11 centres submitted 123 consecutive patients. 112 had a follow up endoscopy. The median age was 67 years (IQR 62-75). 3 dosimetries were used. The mean reduction in Circumferential (C) length was 78% ± 36 and mean reduction in Maximal length (M) was 55% ± 36. 17 patients (15%) developed strictures requiring dilation. There was a higher rate of stricture formation when the 12 J energy was used (p < 0.05). 47 patients had EoT biopsies, 40 (85%) had CR-D and 34(76%) had CR-IM.
CONCLUSIONS
The RFA 360 Express catheter shows reduction in length of baseline BE at 3 months after index treatment, and eradication of intestinal metaplasia and dysplasia at 12 months similar to other studies with earlier devices. It appears that the symptomatic stricture rate is slightly higher than previous series with the HALO 360 catheter. This study was performed as part of the HALO registry and has been approved by the Research Ethics Committee - MREC Number 08/H0714/27 Local project reference 08/0104 Project ID 15,033 IRAS Number 54678 EudraCT 2009-015980-1. Registered on ISRCTN as below: ISRCTN93069556. https://doi.org/10.1186/ISRCTN93069556.
背景
射频消融（RFA）目前用于内镜切除可见肿瘤后治疗 Barrett 食管（BE）相关肿瘤。HALO 360 球囊已用于消融长段 BE。Barrx™360 Express RFA 自定型导管（“RFA Express”）可能能够实现更快的消融时间和改善治疗结果。本文旨在介绍 360 Express 设备的实际数据。
方法
英国和爱尔兰的中心提交了使用 RFA Express 的病例。主要结果是 3 个月时 BE 的消退。次要结果是治疗结束时（EoT）症状性狭窄形成和肠上皮化生（CR-IM）和异型增生（CR-D）的发生率。
结果
11 个中心提交了 123 例连续患者。112 例进行了随访内镜检查。中位年龄为 67 岁（IQR 62-75）。使用了 3 种剂量计。环形（C）长度的平均减少率为 78%±36%，最大长度（M）的平均减少率为 55%±36%。17 例（15%）患者发生需要扩张的狭窄。使用 12 J 能量时，狭窄形成率更高（p<0.05）。47 例患者进行了 EoT 活检，40 例（85%）有 CR-D，34 例（76%）有 CR-IM。
结论
RFA 360 Express 导管在指数治疗后 3 个月显示出基线 BE 长度的减少，并且在 12 个月时消除了肠上皮化生和异型增生，与其他早期设备的研究结果相似。似乎与 HALO 360 导管的先前系列相比，症状性狭窄率略高。这项研究是作为 HALO 注册的一部分进行的，并已获得伦理委员会的批准- MREC 编号 08/H0714/27 本地项目参考号 08/0104 项目 ID 15,033 IRAS 编号 54678 EudraCT 2009-015980-1。在 ISRCTN 上注册如下：ISRCTN93069556。https://doi.org/10.1186/ISRCTN93069556。
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