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The Efficacy of Peroral Endoscopic Myotomy vs Pneumatic Dilation as Treatment for Patients With Achalasia Suffering From Persistent or Recurrent Symptoms After Laparoscopic Heller Myotomy: A Randomized Clinical Trial

贲门失弛缓症 医学 肌切开术 随机对照试验 反流性食管炎 胃肠病学 外科 回流 内科学 优势比 高分辨率测压 海勒肌切开术 食管 疾病
作者
Caroline M.G. Saleh,Pietro Familiari,Barbara A.J. Bastiaansen,Paul Fockens,Jan Tack,Guy E. Boeckxstaens,Raf Bisschops,Aaltje Lei,Marlies P. Schijven,Jan Guido Costamagna,Albert J. Bredenoord
出处
期刊:Gastroenterology [Elsevier]
卷期号:164 (7): 1108-1118.e3 被引量:21
标识
DOI:10.1053/j.gastro.2023.02.048
摘要

For patients with achalasia experiencing persistent or recurrent symptoms after laparoscopic Heller myotomy (LHM), pneumatic dilation (PD) is the most frequently used treatment. Per-oral endoscopic myotomy (POEM) is increasingly being investigated as rescue therapy. This study aimed to determine the efficacy of POEM vs PD for patients with persistent or recurrent symptoms after LHM.This randomized multicenter controlled trial included patients after LHM with an Eckardt score >3 and substantial stasis (≥2 cm) on timed barium esophagogram and randomized to POEM or PD. The primary outcome was treatment success, defined as an Eckardt score of ≤3 and without unscheduled re-treatment. Secondary outcomes included the presence of reflux esophagitis, high-resolution manometry, and timed barium esophagogram findings. Follow-up duration was 1 year after initial treatment.Ninety patients were included. POEM had a higher success rate (28 of 45 patients [62.2%]) than PD (12 of 45 patients [26.7%]; absolute difference, 35.6%; 95% CI, 16.4%-54.7%; P = .001; odds ratio, 0.22; 95% CI, 0.09-0.54; relative risk for success, 2.33; 95% CI, 1.37-3.99). Reflux esophagitis was not significantly different between POEM (12 of 35 [34.3%]) and PD (6 of 40 [15%]). Basal lower esophageal sphincter pressure and integrated relaxation pressure (IRP-4) were significantly lower in the POEM group (P = .034; P = .002). Barium column height after 2 and 5 minutes was significantly less in patients treated with POEM (P = .005; P = .015).Among patients with achalasia experiencing persistent or recurrent symptoms after LHM, POEM resulted in a significantly higher success rate than PD, with a numerically higher incidence of grade A-B reflux esophagitis.NL4361 (NTR4501), https://trialsearch.who.int/Trial2.aspx?TrialID = NTR4501.
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