Endoscopic vs. surgical myotomy in patients with idiopathic achalasia – five-year follow-up of a randomised trial
Bibliographic record
Abstract
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
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".