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多中心国际经口内镜下肌切开术(POEM)后失败再治疗的登记研究。

A multicenter international registry of redo per-oral endoscopic myotomy (POEM) after failed POEM.

机构信息

Division of Gastroenterology & Hepatology, Weill Cornell Medicine, New York, New York, USA.

GastroZentrum Hirslanden, Klinik Hirslanden, Zurich, Switzerland.

出版信息

Gastrointest Endosc. 2017 Jun;85(6):1208-1211. doi: 10.1016/j.gie.2016.10.015. Epub 2016 Oct 15.

Abstract

BACKGROUND AND AIMS

Per-oral endoscopic myotomy (POEM) has become an accepted treatment for patients with achalasia. Despite its excellent efficacy rate of greater than 80%, a small percentage of patients remain symptomatic after the procedure. Limited data exist as to the best management for recurrence of symptoms after POEM. We present the first international, multicenter experience on the efficacy and safety of a repeat POEM in the management of achalasia.

METHODS

Patients who underwent a redo POEM from 15 centers in 9 countries were included in a dedicated registry. Technical success was defined as successful completion of a second myotomy. Clinical success was defined as an Eckardt score of less than or equal to 3 after the second myotomy. Adverse events including anesthesia-related, operative, and postoperative adverse events were recorded.

RESULTS

Forty-six patients were included in the study. The average age was 49.3 ± 16.78 years. Twenty (45%) patients were male. The mean pre-redo-POEM Eckardt score was 4.3 ± 2.48. Technical success was achieved in 46 (100%) patients. Clinical success was achieved in 41 patients (85%). The average post-POEM Eckardt score was 1.64 ± 1.67, with a significant difference of 2.58 (P < .00001). Eight patients (17%) had adverse events consisting of procedural bleeding, all managed endoscopically. There were no deaths. No POEMs were aborted or required surgical conversion or assistance.

DISCUSSION

For patients with persistent symptoms after POEM, repeat POEM appears to be an efficacious and safe technique. Further randomized trials comparing redo POEM versus Heller should be considered. (Clinical trial registration number: NCT02162589.).

摘要

背景与目的

经口内镜下肌切开术(POEM)已成为贲门失弛缓症患者的一种公认治疗方法。尽管其 80%以上的疗效极佳,但仍有一小部分患者在手术后仍有症状。对于 POEM 后症状复发的最佳治疗方法,目前仅有有限的数据。我们首次报道了 9 个国家 15 个中心在 POEM 治疗贲门失弛缓症中的重复应用的疗效和安全性的国际多中心经验。

方法

本研究纳入了一个专门的注册研究中来自 15 个中心的 46 例接受再次 POEM 的患者。技术成功定义为成功完成第二次肌切开术。临床成功定义为第二次肌切开术后 Eckardt 评分小于或等于 3。记录了包括与麻醉、手术和术后相关的不良事件。

结果

本研究纳入了 46 例患者。患者平均年龄为 49.3 ± 16.78 岁,其中 20 例(45%)为男性。 redo-POEM 前的平均 Eckardt 评分为 4.3 ± 2.48。46 例(100%)患者达到了技术成功,41 例(85%)患者达到了临床成功。 POEM 后的平均 Eckardt 评分为 1.64 ± 1.67,差异具有统计学意义(P<0.00001)。8 例(17%)患者出现了不良事件,包括内镜下处理的程序性出血,但均无死亡。没有 POEM 术被取消,也没有需要手术转换或辅助。

讨论

对于 POEM 后仍有持续性症状的患者,再次 POEM 似乎是一种有效且安全的技术。应考虑进一步进行比较 redo-POEM 与 Heller 术的随机对照试验。(临床试验注册号:NCT02162589.)

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