Esophagus to Small Intestine
Gut. 2023;72(8):1442–50
Long versus short peroral endoscopic myotomy for the treatment of achalasia: Results of a non-inferiority randomized controlled trial
Objective: Peroral endoscopic myotomy (POEM) has become standard treatment for achalasia with comparable efficacy to surgery. In most of published series, the length of myotomy is 12–13 cm. Shorter cuts could have the advantage of shorter procedure time and possibly reduced gastroesophageal reflux disease (GERD) rate.
Design: This single-center, patient-blinded, randomized, non-inferiority clinical trial included 200 patients, who were randomly allocated, to receive either a long-POEM (13 cm; 101 patients) or a short-POEM (8 cm; 99 patients). Primary outcome was defined as an Eckardt symptom score of ≤ 3 at 24 months after the procedure; a non-inferiority design was chosen with an accepted success range of 6% between the 2 treatments. Secondary outcomes included operating time, complication rate, postoperative manometry, GERD rate and quality of life.
Results: In the intention-to-treat analysis, clinical success rates were 89.1% in the long-POEM and 98.0% in the short-POEM group, resulting in an absolute between-group difference of -8.9% (90% confidence interval: -14.5 to -3.3). Procedure time was significantly reduced in the short-POEM as compared with the long-POEM group (40 min vs. 50 min, p < 0.0001). Severe adverse events occurred in 1 patient in both groups. No differences were observed in postoperative GERD: Acid exposure > 6% on pH monitoring study at 6 months was seen in 34.3% (long-POEM) versus 31.1% (short-POEM), while endoscopic esophagitis was diagnosed in 37.6% versus 51.5% at 6 months and in 21% versus 24.5% at 24 months. Regular proton-pump inhibitor use was not different either (36.8% vs. 37.5%).
Conclusions: This study demonstrates non-inferiority of a shorter cut length of peroral endoscopic myotomy as compared with the standard treatment, which saved some procedural time. The rate of gastroesophageal reflux disease was not reduced by reducing cutting length.