Endoscopic vs. surgical myotomy in patients with idiopathic achalasia – five-year follow-up of a randomised trial

Aims Endoscopic myotomy (POEM) was shown equally effective as laparoscopic Heller myotomy (LHM) in patients with achalasia at two years in a multicenter randomized trial. Postprocedural reflux esophagitis and treatment with acid inhibitors were more frequent after POEM. Here we report treatment success rate and analysis of post-procedural reflux at the five-year follow-up. Methods In a multicenter, randomized trial, we compared POEM with LHM plus Dor’s fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less without the use of additional treatments at the 5-year follow-up. Secondary end points included esophageal function (manometry, pH-metry), Gastrointestinal Quality of Life Index score, rate of reflux esophagitis and its complications and proportion of patients on proton pump inhibitors. Results A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor’s fundoplication (109 patients). Five-year follow up data was available in 90 POEM and 86 LHM patients. Clinical success rate at the 5-year follow-up was 75.0% (95% CI: 66.2% to 82.1%) in the POEM group and 70.8% (95% CI: 61.7% to 78.5%) in the LHM group. The difference of 4.2% (95% CI: -7.5% to 15.7%) indicates non-inferiority of POEM at the pre-defined 12.5% margin. Decrease in integrated relaxation pressure of the lower esophageal sphincter at 5 years did not differ between the treatment groups (difference, 0.9 mm Hg; 95% CI, -4.3 to 6.3), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, -0.3 points; 95% CI, -8.1 to 6.9). At 5 years, 41.3% of patients (26/63) in the POEM group and 31.0% of patients (18/58) in the LHM group had endoscopic reflux esophagitis (LA C or D 4.8% in the POEM group, n=3, and 3.4% in the LHM group, n=2). The difference between POEM and LHM was not significant (10.2%, 95% CI: -7.0% to 26.8%, p=0.26). At 5 years, 53.4% (47/88) of patients after POEM vs. 38.8% (33/85) after LHM were administered PPIs (difference 14.6%, 95% CI: -0.3% to 28.8%, p=0.07). In those patients in whom gastroesophageal reflux was measured by pH-metry, pathological reflux was significantly more frequent after POEM (51.1%, 23/45) than after LHM (22.2%, 8/36), difference 28.9% (95% CI: 7.7% to 47.3%), p=0.01. Complications such as peptic stricture or Barrett's esophagus were not reported. Conclusions In this randomized trial, POEM was noninferior to LHM plus Dor’s fundoplication in controlling symptoms of achalasia at 5 years. Gastroesophageal reflux was common in both groups, with a tendency of higher rates among POEM patients in some parameters. (Funded by the European Clinical Research Infrastructure Network and others, ClinicalTrials.gov number NCT01601678). Publication History Article published online: 15 April 2024 © 2024. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.