Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Gastronterology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Gastrointest Endosc. 2017 Apr;85(4):708-718.e2. doi: 10.1016/j.gie.2016.08.033. Epub 2016 Sep 5.
The recently developed technique of per-oral endoscopic myotomy (POEM) has been shown to be effective for the therapy of esophageal motility disorders. Limited information is available about POEM adverse events (AEs).
POEM was performed on 241 patients (58% male; mean age, 47.4 ± 16.4 years) under general anesthesia over 61 months. The main outcome was the rate of intra- and post-procedural AEs. Post-procedural checks comprised clinical and laboratory examinations and endoscopy, with further follow-ups performed at 3, 6, and 12 months.
Of the 241 procedures, 238 were successfully completed (mean procedure time, 100.2 ± 39.5 min). Reasons for abortion were excessive submucosal fibrosis preventing submucosal tunneling. Three patients had severe procedural-related AEs (SAE rate, 1.2%); 1 case of pneumothorax required intra-procedural drainage, and 2 patients had delayed SAEs (1 ischemic gastric cardia perforation and 1 hemothorax, both leading to surgery). The overall rate of minor AEs was 31.1%, mainly prolonged intra-procedural bleeding (>15 min hemostasis) and defects of the mucosa overlying the tunnel; none led to clinically relevant signs or symptoms. Patients experiencing any AE had a significantly prolonged hospital stay (P = .037) and a trend toward prolonged procedure time (P = .094). Neck/upper thoracic emphysema and free abdominal air were noted in 31.5% and 35.7%, respectively (95.3% drained), but without relevant sequelae.
POEM has a low rate of SAEs; minor AEs are more frequent but lack a consistent definition. Therefore, based on our experience and literature analysis, we suggest a classification of AEs for POEM. (Clinical trials registration number: NCT01405417.).
经口内镜下肌切开术（POEM）是一种最近发展起来的技术，已被证明对治疗食管动力障碍有效。关于 POEM 的不良事件（AE）的信息有限。
在 61 个月的时间内，在全身麻醉下对 241 例患者（58%为男性；平均年龄 47.4±16.4 岁）进行了 POEM。主要结局是术中及术后 AE 的发生率。术后检查包括临床和实验室检查及内镜检查，并在 3、6 和 12 个月时进行进一步随访。
在 241 例手术中，238 例手术成功完成（平均手术时间 100.2±39.5 分钟）。中止手术的原因是粘膜下过度纤维化，妨碍粘膜下隧道的建立。3 例患者出现严重的与手术相关的 AE（SAE 发生率为 1.2%）；1 例气胸需要术中引流，2 例患者出现迟发性 SAE（1 例缺血性贲门穿孔，1 例血胸，均需手术治疗）。小 AE 的总发生率为 31.1%，主要为术中出血时间延长（>15 分钟止血）和隧道上方粘膜缺损；无患者出现与临床相关的症状或体征。发生任何 AE 的患者住院时间明显延长（P=0.037），手术时间延长趋势（P=0.094）。颈部/上胸部气肿和游离腹腔气分别为 31.5%和 35.7%（95.3%经引流），但无相关后遗症。
POEM 的 SAE 发生率较低；小 AE 更为常见，但尚无明确的定义。因此，根据我们的经验和文献分析，我们建议对 POEM 的 AE 进行分类。（临床试验注册号：NCT01405417。）
