• Yuki B Werner, Bengt Hakanson, Jan Martinek, Alessandro Repici, von RahdenBurkhard H ABHAFrom the Departments of Interdisciplinary Endoscopy (Y.B.W., T.N., T.R.), Epidemiology and Statistics (J.F.K.), and General, Visceral, and Thoracic Surgery (O.M., J.I.), University Hospital Hamburg-Eppendorf, and the Department of, Albert J Bredenoord, Raf Bisschops, Helmut Messmann, Marius C Vollberg, Tania Noder, Jan F Kersten, Oliver Mann, Jakob Izbicki, Alexander Pazdro, Uberto Fumagalli, Riccardo Rosati, Christoph-Thomas Germer, Marlies P Schijven, Alice Emmermann, Daniel von Renteln, Paul Fockens, Guy Boeckxstaens, and Thomas Rösch.
• From the Departments of Interdisciplinary Endoscopy (Y.B.W., T.N., T.R.), Epidemiology and Statistics (J.F.K.), and General, Visceral, and Thoracic Surgery (O.M., J.I.), University Hospital Hamburg-Eppendorf, and the Department of Surgery, Israelitic Hospital (A.E.), Hamburg, the Department of Surgery, University Hospital Würzburg, Würzburg (B.H.A.R., C.-T.G.), and the Department of Gastroenterology, University Hospital Augsburg, Augsburg (H.M.) - all in Germany; the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, and the Department of Surgery, Ersta Hospital, Stockholm (B.H.); the Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine (J.M.), and the 3rd Department of Surgery, 1st Faculty of Medicine, Charles University in Prague and University Hospital Motol (A.P.) - all in Prague, Czech Republic; the Departments of Gastroenterology (A.R.) and Digestive Surgery (U.F.), Istituto Clinico Humanitas Rozzano, and the Department of Digestive Surgery, IRCCS Ospedale San Raffaele (R.R.) - both in Milan; Amsterdam University Medical Centers location AMC, Amsterdam Gastroenterology and Metabolism (A.J.B., P.F.) and Surgery (M.P.S.), University of Amsterdam, Amsterdam; the Department of Gastroenterology and Hepatology, University Hospitals Leuven, and Translational Research Center for Gastrointestinal Disorders, Katholieke Universiteit Leuven, Leuven, Belgium (R.B., G.B.); the Department of Psychology, Harvard University, Cambridge, MA (M.C.V.); and the Division of Gastroenterology, Montreal University Hospital and Research Center, Montreal (D.R.).
• N. Engl. J. Med. 2019 Dec 5; 381 (23): 2219-2229.

BackgroundPneumatic dilation and laparoscopic Heller's myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study results.MethodsIn a multicenter, randomized trial, we compared POEM with LHM plus Dor's fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indicating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of -12.5 percentage points was used in the primary analysis. Secondary end points included adverse events, esophageal function, Gastrointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux.ResultsA total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor's fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval [CI], -8.7 to 11.4; P = 0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal function from baseline to 24 months, as assessed by measurement of the integrated relaxation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, -0.75 mm Hg; 95% CI, -2.26 to 0.76), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, -4.01 to 4.28). At 3 months, 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44% and 29%.ConclusionsIn this randomized trial, POEM was noninferior to LHM plus Dor's fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.).Copyright © 2019 Massachusetts Medical Society.

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