Safety and efficacy of peroral endoscopic myotomy with standard myotomy versus short myotomy for treatment-naïve patients with type II achalasia: a prospective randomized trial

Abstract

Background and aims: Peroral endoscopic myotomy (POEM) has emerged as an effective endoscopic treatment modality for achalasia. However, there is no consensus regarding the length of muscle bundle dissection during POEM. The most commonly used approach is standard myotomy (about 10 cm). We herein compared the outcomes between standard myotomy versus short myotomy for the management of treatment-naïve patients with type II achalasia.

Methods: This was a prospective, single-center, randomized trial in China. Previously untreated adults with a clinical diagnosis of type II achalasia, confirmed by manometric testing, were enrolled between February 2018 and February 2019. Patients were randomly assigned to POEM with standard myotomy or short myotomy. Clinical data on demographic characteristics, operative parameters, pre- and postoperative Eckardt scores, esophageal manometry results, 24-hour pH test, and adverse events were recorded and compared between the 2 groups.

Results: Of 100 randomized patients, 94 underwent treatment (48 in the standard myotomy group and 46 in the short myotomy group), and 91 (97%) completed the study. POEM was successfully accomplished in most patients (97.8%). The primary outcome of treatment success occurred in 45 of 48 patients (93.8%) in the standard myotomy group versus 44 of 46 (95.7%) in the short myotomy group, with no statistically significant difference between the 2 groups (P = .520). There were no significant between-group differences in postoperative esophageal manometry, Eckardt score, diameter of the esophageal lumen, quality of life, procedure-related adverse events, or reflux esophagitis (P > .05). Postoperative abnormal esophageal acid exposure occurred more often in the standard myotomy group than in the short myotomy group (21/48 patients [43.8%] vs 11/46 patients [23.9%], P = .042). Meanwhile, the short myotomy group showed a significant reduction in total procedure time compared with the standard myotomy group (31.2 ± 15.3 minutes vs 45.6 ± 16.2 minutes, respectively, P < .05).

Conclusions: Among treatment-naïve patients with type II achalasia, standard and short POEM were comparable in terms of providing treatment efficacy and improving quality of life at 1 year, whereas short POEM is technically simpler to perform and requires less procedure time. Moreover, the short POEM approach resulted in fewer cases of postoperative abnormal esophageal acid exposure. (Clinical trial registration number: ChiCTR1800014989.).