Peroral endoscopic myotomy vs laparoscopic myotomy and partial fundoplication for esophageal achalasia: A single-center randomized controlled trial

Abstract

BACKGROUND Achalasia is a rare benign esophageal motor disorder characterized by incomplete relaxation of the lower esophageal sphincter (LES). The treatment of achalasia is not curative, but rather is aimed at reducing LES pressure. In patients who have failed noninvasive therapy, surgery should be considered. Myotomy with partial fundoplication has been considered the first-line treatment for non-advanced achalasia. Recently, peroral endoscopic myotomy (POEM), a technique that employs the principles of submucosal endoscopy to perform the equivalent of a surgical myotomy, has emerged as a promising minimally invasive technique for the management of this condition. AIM To compare POEM and laparoscopic myotomy and partial fundoplication (LM-PF) regarding their efficacy and outcomes for the treatment of achalasia. METHODS Forty treatment-naive adult patients who had been diagnosed with achalasia based on clinical and manometric criteria (dysphagia score ≥ II and Eckardt score > 3) were randomized to undergo either LM-PF or POEM. The outcome measures were anesthesia time, procedure time, symptom improvement, reflux esophagitis (as determined with the Gastroesophageal Reflux Disease Questionnaire), barium column height at 1 and 5 min (on a barium esophagogram), pressure at the LES, the occurrence of adverse events (AEs), length of stay (LOS), and quality of life (QoL). RESULTS There were no statistically significant differences between the LM-PF and POEM groups regarding symptom improvement at 1, 6, and 12 mo of follow-up ( P = 0.192, P = 0.242, and P = 0.242, respectively). However, the rates of reflux esophagitis at 1, 6, and 12 mo of follow-up were significantly higher in the POEM group ( P = 0.014, P < 0.001, and P = 0.002, respectively). There were also no statistical differences regarding the manometry values, the occurrence of AEs, or LOS. Anesthesia time and procedure time were significantly shorter in the POEM group than in the LM-PF group (185.00 ± 56.89 and 95.70 ± 30.47 min vs 296.75 ± 56.13 and 218.75 ± 50.88 min, respectively; P = 0.001 for both). In the POEM group, there were improvements in all domains of the QoL questionnaire, whereas there were improvements in only three domains in the LM-PF group. CONCLUSION POEM and LM-PF appear to be equally effective in controlling the symptoms of achalasia, shortening LOS, and minimizing AEs. Nevertheless, POEM has the advantage of improving all domains of QoL, and shortening anesthesia and procedure times but with a significantly higher rate of gastroesophageal reflux.

Gastroesophageal Reflux Waning Over Time in Endoscopic Versus Surgical Myotomy for the Treatment of Achalasia: A Systematic Review and Meta-Analysis

“…The initial search identified 14,540 articles, resulting in 33 systematic reviews, composed of 30 observational studies (Table 1) and three RCTs [6,46,47] (Table 2). The study by Trieu et al [41] was excluded from the meta-analysis by evaluating the same database already included in Khoraki et al [29].…”

“…The study by Trieu et al [41] was excluded from the meta-analysis by evaluating the same database already included in Khoraki et al [29]. The same occurred for the study by Conte et al [46], which was replaced by de Moura et al [47], who published updated data from the same sample. The final PRISMA flow diagram (Figure 1) resulted in 29 observational studies [42][43][44][45] and two RCTs [6,47], evaluating 3,049 patients who underwent POEM and 10,865 who underwent HMF, totaling 13,914 patients.…”

“…Studies represented in the forest plot: two observational studies [34,36] and two randomized controlled trials [6,47] POEM: peroral endoscopic myotomy; M-H: Mantel-Haenszel; CI: confidence interval; GERD: gastroesophageal reflux disease…”

“…Clinical success: Adequate data were found in 21 studies, consisting of 19 observational studies [19,21,23,25,27,28,31,32,[34][35][36][37][38][39][40][42][43][44][45] and two RCTs [6,47], totaling 1,604 patients. There was no significant heterogeneity.…”

“…Operative duration: A total of 18 studies analyzed OD, consisting of 16 observational studies [16][17][18][19][20]23,26,[30][31][32]34,35,38,39,42,45] and two RCTs [6,47], with a total of 1,275 patients. There was high heterogeneity among the studies.…”