Efficacy and safety of full-thickness versus circular muscle myotomy in peroral endoscopic myotomy: a randomized...

Peroral endoscopic myotomy 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 noninferiority trial primarily determined whether FTM achieved clinical success noninferior to CMM.

This single-center, randomized noninferiority trial enrolled 69 patients with type I or II AC assigned to the FTM group (n = 34) or the CMM group (n = 35). The primary outcome was clinical success (Eckardt score ≤3) at 6 months after the procedure. A noninferiority margin of -10% was prespecified. Secondary outcomes included procedure-related metrics, safety outcomes or adverse events, physiological and anatomical outcomes, and GERD-related outcomes.

In the intention-to-treat analysis, clinical success rates were 91.2% in the FTM group and 85.7% in the CMM group, with a group difference of 5.5% (90% CI, -7.1% to 18.1%). Because the lower CI bound (-7.1%) was above -10%, FTM was noninferior to CMM. FTM was associated with significantly higher insufflation-related events (32.35% vs 11.43%; P = .035). There was a trend toward more frequent moderate-to-severe intraoperative bleeding in the FTM group (41.18% vs 22.86%; P = .103). FTM resulted in significantly lower basal LES pressure than CMM (6.85 vs 11.70 mm Hg; P = .024). Postoperative esophagitis showed a numerical trend toward an increase in the FTM group (36.36% vs 18.18%; P = .097).

FTM was noninferior to CMM in short-term efficacy. However, FTM was associated with a significantly higher incidence of insufflation-related events and demonstrated a potential increase in postprocedural reflux. Despite the comparable efficacy, the disadvantages in the safety of FTM limit its recommendation as a routine alternative to CMM in the management of AC.