Familiari Pietro, Borrelli de Andreis Federica, Landi Rosario, Mangiola Francesca, Boskoski Ivo, Tringali Andrea, Perri Vincenzo, Costamagna Guido
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, RM, Italy
Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Roma, RM, Italy.
Gut. 2023 Aug;72(8):1442-1450. doi: 10.1136/gutjnl-2021-325579. Epub 2023 Apr 18.
Peroral endoscopic myotomy (POEM) has become standard treatment for achalasia with comparable efficacy to surgery. In most of published series, the length of myotomy is 12-13 cm. Shorter cuts could have the advantage of shorter procedure time and possibly reduced gastro-oesophageal reflux disease (GORD) rate.
This single-centre, patient-blinded, randomised, non-inferiority clinical trial included 200 patients, who were randomly allocated, to receive either a long-POEM (13 cm; 101 patients) or a short-POEM (8 cm; 99 patients). Primary outcome was defined as an Eckardt symptom score of ≤3 at 24 months after the procedure; a non-inferiority design was chosen with an accepted success range of 6% between the two treatments. Secondary outcomes included operating time, complication rate, postoperative manometry, GORD rate and quality of life.
In the intention-to-treat analysis, clinical success rates were 89.1% in the long-POEM and 98.0% in the short-POEM group, resulting in an absolute between-group difference of -8.9% (90% CI -14.5 to -3.3).Procedure time was significantly reduced in the short-POEM as compared with the long-POEM group (40 vs 50 min, p<0.0001). Severe adverse events occurred in one patient in both groups.No differences were observed in postoperative GORD: acid exposure >6% on pH monitoring study at 6 months was seen in 34.3% (long-POEM) vs 31.1% (short-POEM), while endoscopic oesophagitis was diagnosed in 37.6% vs 51.5% at 6 months and in 21% vs 24.5% at 24 months. Regular proton pump inhibitor use was not different either (36.8% vs 37.5%).
Our study demonstrates non-inferiority of a shorter cut length of POEM as compared with the standard treatment, which saved some procedural time. GORD rate was not reduced by reducing cutting length.
NCT03450928.
经口内镜下肌切开术（POEM）已成为贲门失弛缓症的标准治疗方法，其疗效与手术相当。在大多数已发表的系列研究中，肌切开术的长度为12 - 13厘米。较短的切口可能具有手术时间更短以及可能降低胃食管反流病（GORD）发生率的优势。
这项单中心、患者盲法、随机、非劣效性临床试验纳入了200例患者，他们被随机分配接受长POEM（13厘米；101例患者）或短POEM（8厘米；99例患者）。主要结局定义为术后24个月时埃卡德特症状评分≤3；选择非劣效性设计，两种治疗之间可接受的成功范围为6%。次要结局包括手术时间、并发症发生率、术后测压、GORD发生率和生活质量。
在意向性分析中，长POEM组的临床成功率为89.1%，短POEM组为98.0%，组间绝对差异为 - 8.9%（90%CI - 14.5至 - 3.3）。与长POEM组相比，短POEM组的手术时间显著缩短（40分钟对50分钟，p<0.0001）。两组均有1例患者发生严重不良事件。术后GORD方面未观察到差异：在6个月时，pH监测研究中酸暴露>6%的情况在长POEM组为34.3%，短POEM组为31.1%；而在6个月时内镜下食管炎的诊断率分别为37.6%和51.5%，在24个月时分别为21%和24.5%。常规质子泵抑制剂的使用情况也无差异（36.8%对37.5%）。
我们的研究表明，与标准治疗相比，较短切口长度的POEM具有非劣效性，且节省了一些手术时间。缩短切口长度并未降低GORD发生率。
NCT03450928。
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