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

Gastroenterology. 2023 Jun;164(7):1108-1118.e3. doi: 10.1053/j.gastro.2023.02.048. Epub 2023 Mar 11.

Abstract

Background & aims: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

Netherlands trial registry: NL4361 (NTR4501), https://trialsearch.who.int/Trial2.aspx?TrialID = NTR4501.

Keywords: Eckardt Score; High-Resolution Manometry; Laparoscopic Heller Myotomy; Per-Oral Endoscopic Myotomy; Pneumatic Dilation.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Barium
  • Dilatation / adverse effects
  • Dilatation / methods
  • Esophageal Achalasia* / diagnosis
  • Esophageal Achalasia* / surgery
  • Esophageal Sphincter, Lower / surgery
  • Esophagitis, Peptic* / diagnosis
  • Esophagitis, Peptic* / etiology
  • Esophagitis, Peptic* / therapy
  • Heller Myotomy* / adverse effects
  • Heller Myotomy* / methods
  • Humans
  • Natural Orifice Endoscopic Surgery* / adverse effects
  • Natural Orifice Endoscopic Surgery* / methods
  • Treatment Outcome

Substances

  • Barium

Associated data

  • NTR/NTR4501