BACKGROUND AND AIMS Peroral endoscopic myotomy (POEM) is an available treatment modalities for achalasia. The reported efficacy of POEM in the only prospective multicenter study was 82%; however, a retrospective multicenter study in Japan reported a higher efficacy rate of 95%. The aim of this study was to prospectively verify treatment outcomes after POEM at multiple facilities in Japan. METHODS This was a prospective single-arm trial of POEM for achalasia at 8 facilities in Japan between April 2016 and March 2018 to evaluate its safety and efficacy. Patients were re-evaluated at 3 months and up to 1 year after POEM. RESULTS Among the 233 patients with achalasia who underwent POEM, procedure-related adverse events occurred in 24 patients (10.3%), none of whom required surgical intervention. In the 207 patients satisfying the inclusion criteria, the efficacy rate of POEM, defined by an Eckardt score ≤3 at 1 year, was 97.4% (95% CI, 95.3%-99.7%). The Eckardt score decreased significantly from 6.6 ± 2.0 preoperatively to 1.1 ± 1.1, 1 year after POEM. Postoperative reflux esophagitis, severe reflux esophagitis, and symptomatic GERD were reported in 54.2%, 5.6%, and 14.7%, respectively, and proton pump inhibitors were administered in 21.1%. CONCLUSIONS Our prospective multicenter study in Japan showed greater efficacy of POEM for achalasia compared with the results of a previous prospective multicenter study. POEM is safe and highly effective for at least 1 year. (Clinical trial registration number: UMIN 000021550.).

中文翻译：

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经口内镜肌切开术治疗门失弛缓症：日本的一项前瞻性多中心研究。

背景与目的经口内镜下肌切开术（POEM）是一种可用于门失弛缓症的治疗方法。在唯一的前瞻性多中心研究中，POEM的报道疗效为82％；但是，日本的一项多中心回顾性研究报告，其有效率高达95％。这项研究的目的是前瞻性地验证在日本多家机构进行POEM后的治疗效果。方法这是一项POEM在2016年4月至2018年3月期间在日本的8个设施中对门失弛缓症进行前瞻性单臂试验的方法，以评估其安全性和有效性。在POEM后3个月和最长1年时对患者进行重新评估。结果在233例接受POEM的门失弛缓患者中，有24例（10.3％）发生了与手术相关的不良事件，其中无一例需要手术干预。在满足纳入标准的207位患者中，通过1年的Eckardt评分≤3定义的POEM的有效率为97.4％（95％CI，95.3％-99.7％）。POEM术后一年，Eckardt评分从术前的6.6±2.0降至1.1±1.1。术后反流性食管炎，严重反流性食管炎和有症状的GERD分别报道为54.2％，5.6％和14.7％，质子泵抑制剂的使用率为21.1％。结论我们在日本的前瞻性多中心研究显示，与先前的前瞻性多中心研究相比，POEM对for门失弛缓症的疗效更高。POEM安全且高效至少一年。（临床试验注册号：UMIN000021550。）。POEM术后1年，术前0至1.1±1.1。术后反流性食管炎，严重反流性食管炎和有症状的GERD分别报道为54.2％，5.6％和14.7％，质子泵抑制剂的使用率为21.1％。结论我们在日本的前瞻性多中心研究显示，与先前的前瞻性多中心研究相比，POEM对for门失弛缓症的疗效更高。POEM安全且高效至少一年。（临床试验注册号：UMIN000021550。）。POEM术后1年，术前0至1.1±1.1。术后反流性食管炎，严重反流性食管炎和有症状的GERD分别报道为54.2％，5.6％和14.7％，质子泵抑制剂的使用率为21.1％。结论我们在日本的前瞻性多中心研究表明，与先前的前瞻性多中心研究相比，POEM对for门失弛缓症的疗效更高。POEM安全且高效至少一年。（临床试验注册号：UMIN000021550。）。结论我们在日本的前瞻性多中心研究显示，与先前的前瞻性多中心研究相比，POEM对for门失弛缓症的疗效更高。POEM安全且高效至少一年。（临床试验注册号：UMIN000021550。）。结论我们在日本的前瞻性多中心研究显示，与先前的前瞻性多中心研究相比，POEM对for门失弛缓症的疗效更高。POEM安全且高效至少一年。（临床试验注册号：UMIN000021550。）。