Efficacy and Safety of Full-Thickness Versus Circular Muscle Myotomy in Peroral Endoscopic Myotomy: A Randomized Controlled Non-inferiority Trial
Abstract
BACKGROUND AND AIM
Peroral Endoscopic Myotomy (POEM) is a standard treatment for achalasia (AC). The conventional approach involves circular muscle myotomy (CMM), but full-thickness myotomy (FTM) may offer more profound lower esophageal sphincter (LES) reduction. This randomized controlled non-inferiority trial primarily determined whether FTM achieved clinical success non-inferior to CMM.
METHODS
This single-center, randomized non-inferiority trial enrolled 69 patients with Type I/II achalasia assigned to FTM (n = 34) or CMM (n = 35). The primary outcome was clinical success (Eckardt score ≤ 3) 6 months post-procedure. A non-inferiority margin of -10% was pre-specified. Secondary outcomes included procedure-related metrics, safety outcomes or adverse events, physiological and anatomical outcomes, and gastroesophageal reflux disease (GERD)-related outcomes.
RESULTS
In the intention-to-treat analysis, clinical success rates were 91.2% (FTM) and 85.7% (CMM), with a group difference of 5.46% (90% CI: -7.1% to 18.1%). Since the lower CI bound (-7.1%) was above -10%, FTM was non-inferior to CMM. FTM was associated with significantly higher insufflation-related events (32.35% vs. 11.43%, P = 0.035). There was a trend towards more frequent moderate-to-severe intraoperative bleeding in FTM (41.18% vs. 22.86%, P = 0.103). FTM resulted in significantly lower basal lower esophageal sphincter pressure compared to CMM (6.85 vs. 11.70 mmHg, P = 0.024). Post-operative esophagitis showed a…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 69 participants or records.
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