Safety and efficacy of peroral endoscopic myotomy with standard myotomy versus short myotomy for treatment-naive patients with type II achalasia: a prospective randomized trial
Safety and efficacy of peroral endoscopic myotomy with standard myotomy versus short myotomy for treatment-naive patients with type II achalasia: a prospective randomized trial
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DOI：
10.1016/j.gie.2020.10.006
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发表时间：
2021-05-13
影响因子：
7.7
通讯作者：
Liu, Deliang
中科院分区：
文献类型：
--
作者：
Gu, Li;Ouyang, Zhenghui;Liu, Deliang
背景和目的：经口内镜下肌切开术（POEM）已成为贲门失弛缓症的有效内镜治疗方式。然而，对于 POEM 期间肌束解剖的长度尚未达成共识。最常用的方法是标准肌切开术（约 10 厘米）。我们在此比较了标准肌切开术与短肌切开术治疗初治 II 型贲门失弛缓症患者的结果。方法：这是在中国进行的一项前瞻性、单中心、随机试验。 2018 年 2 月至 2019 年 2 月期间，纳入了临床诊断为 II 型贲门失弛缓症且经测压测试证实且未经治疗的成人。患者被随机分配至接受标准肌切开术或短肌切开术的 POEM。记录并比较两组之间的人口统计学特征、手术参数、术前和术后 Eckardt 评分、食管测压结果、24 小时 pH 测试和不良事件等临床数据。 结果：100 名随机患者中，94 例接受治疗（标准肌切开术组 48 例，短肌切开术组 46 例），91 例（97%）完成研究。大多数患者 (97.8%) 成功完成 POEM。标准肌切开术组 48 名患者中有 45 名 (93.8%) 出现治疗成功的主要结果，而短肌切开术组 46 名患者中有 44 名 (95.7%) 出现治疗成功的主要结果，两组之间没有统计学显着差异 (P = 0.520)。术后食管测压、Eckardt 评分、食管管腔直径、生活质量、手术相关不良事件或反流性食管炎组间无显着差异 (P > .05)。标准肌切开术组术后异常食管酸暴露的发生率高于短肌切开术组（21/48 例患者 [43.8%] vs 11/46 例患者 [23.9%]，P = 0.042）。同时，与标准肌切开术组相比，短肌切开术组的总手术时间显着缩短（分别为 31.2 +/- 15.3 分钟 vs 45.6 +/- 16.2 分钟，P < .05）。结论：在未经治疗的 II 型贲门失弛缓症患者中，标准和短 POEM 在提供治疗效果和改善 1 年生活质量方面具有可比性，而短 POEM 在技术上更易于执行，所需的手术量也更少。时间。此外，短 POEM 方法减少了术后异常食管酸暴露的病例。
Background and Aims: Peroral endoscopic myotomy (POEM) has emerged as an effective endoscopic treatment modality for achalasia. However, there is no consensus regarding the length of muscle bundle dissection during POEM. The most commonly used approach is standard myotomy (about 10 cm). We herein compared the outcomes between standard myotomy versus short myotomy for the management of treatment-naive patients with type II achalasia.Methods: This was a prospective, single-center, randomized trial in China. Previously untreated adults with a clinical diagnosis of type II achalasia, confirmed by manometric testing, were enrolled between February 2018 and February 2019. Patients were randomly assigned to POEM with standard myotomy or short myotomy. Clinical data on demographic characteristics, operative parameters, pre- and postoperative Eckardt scores, esophageal manometry results, 24-hour pH test, and adverse events were recorded and compared between the 2 groups.Results: Of 100 randomized patients, 94 underwent treatment (48 in the standard myotomy group and 46 in the short myotomy group), and 91 (97%) completed the study. POEM was successfully accomplished in most patients (97.8%). The primary outcome of treatment success occurred in 45 of 48 patients (93.8%) in the standard myotomy group versus 44 of 46 (95.7%) in the short myotomy group, with no statistically significant difference between the 2 groups (P = .520). There were no significant between-group differences in postoperative esophageal manometry, Eckardt score, diameter of the esophageal lumen, quality of life, procedure-related adverse events, or reflux esophagitis (P > .05). Postoperative abnormal esophageal acid exposure occurred more often in the standard myotomy group than in the short myotomy group (21/48 patients [43.8%] vs 11/46 patients [23.9%], P = .042). Meanwhile, the short myotomy group showed a significant reduction in total procedure time compared with the standard myotomy group (31.2 +/- 15.3 minutes vs 45.6 +/- 16.2 minutes, respectively, P < .05).Conclusions: Among treatment-naive patients with type II achalasia, standard and short POEM were comparable in terms of providing treatment efficacy and improving quality of life at 1 year, whereas short POEM is technically simpler to perform and requires less procedure time. Moreover, the short POEM approach resulted in fewer cases of postoperative abnormal esophageal acid exposure.