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经口内镜肌切开术:贲门失弛缓症短段与长段食管肌切开术的随机对照非劣效性试验。

Peroral Endoscopic Myotomy: Short Versus Long Esophageal Myotomy for Achalasia Cardia: A Randomized Controlled Noninferiority Trial.

机构信息

Departments of Gastroenterology.

Biostatistics & Health Informatics, Sanjay Gandhi Post Graduate Institute of Medical Sciences.

出版信息

Surg Laparosc Endosc Percutan Tech. 2024 Oct 1;34(5):445-451. doi: 10.1097/SLE.0000000000001303.

Abstract

BACKGROUND AND AIMS

The appropriate length of esophageal myotomy in peroral endoscopic myotomy (POEM) for achalasia cardia remains unclear. This study aimed to compare the outcome of short (≤3 cm) and long (≥6 cm) esophageal myotomy in patients with type I and II achalasia cardia.

METHODS

This single-blinded, randomized controlled noninferiority trial was conducted at a tertiary center between July 2021 and December 2021. Patients with achalasia types I and II were randomized into short (≤3 cm) and long (≥6 cm) esophageal myotomy groups. The primary outcome of the study was clinical success (Eckardt score ≤3) 1 year after the procedure. The secondary outcomes included a comparison of technical success, operating duration, occurrence of intraoperative adverse events, alterations in integrated relaxation pressure (IRP), change in barium column height after 5 minutes (1 mo), and gastroesophageal reflux disease (3 mo) between the groups.

RESULTS

Fifty-four patients were randomized into the short (n=27) or long (n=27) esophageal myotomy groups. Technical success rates were 100% (27/27) and 96.3% (26/27) in short myotomy (SM) and long myotomy (LM) groups, respectively. The clinical success rates were 96.3% (26/27) and 96.2% (25/26) in the SM and LM groups, respectively ( P =0.998). The mean (±SD) length of the esophageal myotomy was 2.75±0.36 cm in the SM and 6.69±1.35 cm in the LM groups ( P <0.001). The mean (±SD) procedure time for the SM and LM groups was 61.22±8.44 and 82.42±14.70 minutes ( P <0.001), respectively. The mean integrated relaxation pressure (IRP), Eckardt score, adverse events, reflux esophagitis, symptomatic gastroesophageal reflux disease, and esophageal acid exposure (>6%) did not differ significantly between the 2 groups following POEM treatment.

CONCLUSIONS

Short myotomy is noninferior to long myotomy in terms of clinical success, gastroesophageal reflux disease, and intraoperative adverse events at the short-term follow-up ( P >0.05). Short myotomy resulted in a reduced operative time ( P <0.05).

摘要

背景和目的

贲门失弛缓症经口内镜下肌切开术(POEM)中食管肌切开的适当长度仍不清楚。本研究旨在比较贲门失弛缓症 I 型和 II 型患者中短(≤3cm)和长(≥6cm)食管肌切开术的效果。

方法

这是一项在 2021 年 7 月至 2021 年 12 月期间在一家三级中心进行的单盲、随机对照非劣效性试验。将贲门失弛缓症 I 型和 II 型患者随机分为短(≤3cm)和长(≥6cm)食管肌切开组。研究的主要结局是术后 1 年临床成功(Eckardt 评分≤3)。次要结局包括两组间技术成功率、手术时间、术中不良事件发生情况、整体松弛压(IRP)变化、5 分钟后钡柱高度变化(1 个月)和胃食管反流病(3 个月)的比较。

结果

54 例患者被随机分为短(n=27)或长(n=27)食管肌切开组。短肌切开(SM)和长肌切开(LM)组的技术成功率分别为 100%(27/27)和 96.3%(26/27)。SM 和 LM 组的临床成功率分别为 96.3%(26/27)和 96.2%(25/26)(P=0.998)。SM 组和 LM 组的食管肌切开长度分别为 2.75±0.36cm 和 6.69±1.35cm(P<0.001)。SM 和 LM 组的平均(±SD)手术时间分别为 61.22±8.44 分钟和 82.42±14.70 分钟(P<0.001)。POEM 治疗后,两组间综合松弛压(IRP)、Eckardt 评分、不良事件、反流性食管炎、症状性胃食管反流病和食管酸暴露(>6%)无显著差异。

结论

在短期随访中(P>0.05),短肌切开术在临床成功率、胃食管反流病和术中不良事件方面与长肌切开术无差异。短肌切开术可缩短手术时间(P<0.05)。

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