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Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia: 5-Year Follow-Up of a Randomised Controlled Trial
24 Pages Posted: 9 Oct 2024
More...Abstract
Background: In a multicenter and randomized trial, endoscopic myotomy (POEM) was shown to be equally effective as laparoscopic Heller myotomy plus Dor´s fundoplication (LHM) in patients with idiopathic achalasia two years after the procedure. Postprocedural reflux esophagitis and treatment with proton pump inhibitors (PPIs) were more frequent after POEM. Here we report the results at the five-year follow-up.
Methods: Primary endpoint was clinical succes, defined as an Eckardt symptom score of 3 or less without the use of additional treatments at five years. Secondary end points included parameters of post-procedural reflux (reflux esophagitis and its complications, pH-metry and proportion of patients on PPIs).
Findings: Of the 221 patients initially assigned to POEM (112 patients) or LHM (109 patients), five-year follow up data was available for 90 POEM and 86 LHM patients. Clinical success rate was 75·0% (95% CI: 66·2% to 82·1%) after POEM and 70·8% (95% CI: 61·7% to 78·5%) after LHM. The difference of 4·2% (95% CI: -7·5% to 15·7%) indicates non-inferiority of POEM at the pre-defined 12·5% margin. At five years, 41·3% of patients (26/63) after POEM and 31·0% of patients (18/58) after LHM had reflux esophagitis. The difference between POEM and LHM was not significant (10·2%, 95% CI: -7·0% to 26·8%, p=0·26). Severe esophagitis was infrequent (Los Angeles class C or D: 4·8% after POEM and 3·4% after LHM). Complications such as peptic stricture were not reported. At five years, 53·4% (47/88) of patients after POEM vs. 38·8% (33/85) after LHM were administered PPIs (difference 14·6%, 95% CI: -0·3% to 28·8%, p=0·07).
Interpretation: POEM continued to be non-inferior to LHM plus Dor’s fundoplication in controlling symptoms of achalasia at five years. Gastroesophageal reflux was common in both groups, with a tendency of higher rates with POEM.Funding European Clinical Research Infrastructure Network and others (see Acknowledgements).
Trial Registration: ClinicalTrials.gov number, NCT01601678.
Funding: Supported by the European Clinical Research Infrastructure Network (ECRIN); Hamburgische Stiftung für Wissenschaften, Entwicklung und Kultur Helmut und Hannelore Greve (Hamburg, Germany); by Dr. med. Carl-August Skröder Stiftung (Hamburg, Germany); Dr. Gerhard Büchtemann Stiftung (Hamburg, Germany); Agnes-Graefe Stiftung (Hamburg, Germany); Georg und Jürgen Rickertsen Stiftung (Hamburg, Germany); Reinhard Frank Stiftung (Hamburg, Germany); Johann Max Böttcher Stiftung (Hamburg, Germany); Richard und Annemarie Wolf Stiftung (Knittlingen, Germany); Olympus Europa (Hamburg, Germany), which provided funding for the training of personnel at the European centers through POEM Grants 206/7 and 2017/18; the German Society for Gastroenterology and Metabolism and Olympus Europe Foundation (Endoscopy Research Award 2012); a prize awarded at the United European Gastroenterology Week 2010 conference; and the Olympus EuroNOTES Research Fund Program. The trial was also supported by Harvard Catalyst, the Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health Award UL 1TR002541), and by financial contributions from Harvard University and its affiliated academic health care centers.
Declaration of Interest: KH, JM, BH, AR, HM, TR, OM, TH, RUF, RR, CTG, AE, GB, JM, YBW, MV, JI have nothing to disclose. Dr. von Rahden reports other from Karl Storz GmbH, Tuttlingen, Germany, outside the submitted work. Dr. von Renteln reports grants and personal fees from Boston Scientific, grants and personal fees from Pendopharm, grants from Vantage, grants from ERBE, grants from Pentax, outside the submitted work. Dr. Bisschops reports grants and personal fees from Pentax, grants and personal fees from Fujifilm, grants and personal fees from Cook, other from Erbe, other from Olympus, personal fees from Norgine, personal fees and other from Medivators, personal fees and other from Boston scientific, outside the submitted work. Dr. Bredenoord reports grants and personal fees from Laborie, personal fees from Esocap, grants and personal fees from Diversatek, grants and personal fees from Medtronic, personal fees and other from DrFalkPharma, personal fees from Calypso Biotech, personal fees from Robarts, personal fees from Reckett Benkiser, personal fees and other from Regeneron, personal fees from Celgene, grants and personal fees from Bayer, grants and personal fees from Norgine, personal fees from AstraZeneca, personal fees from Almirall, personal fees from Allergan, outside the submitted work. Dr. Fockens reports personal fees from Cook Endoscopy, personal fees from Olympus, personal fees from Ethicon Endosurgery, grants from Boston Scientific, outside the submitted work. Dr. Rösch reports grants from ECRIN (European Clinical Research Infrastructure Network ) ID 77, grants from Hamburg Greve Foundation (Hamburgische Stiftung für Wissenschaften, Entwicklung und Kultur Helmut und Hannelore Greve) Hamburg, Germany, grants from Carl- August Skröder Foundation (Dr. med. Carl-August Skröder – Stiftung) Hamburg, Germany, grants from Büchtemann Foundation (Dr. Gerhard Büchtemann- Stiftung) Hamburg, Germany, grants from AgnesGraefe Foundation (Agnes-Graefe - Stiftung) Hamburg, Germany, grants from Rickertsen Foundation (Georg und Jürgen Rickertsen - Stiftung) Hamburg, Germany, grants from Frank Foundation (Reinhard Frank - Stiftung) Hamburg, Germany, grants from Wolf Foundation (Richard und Annemarie Wolf – Stiftung) Knittlingen, Germany, grants from Olympus Europa SE & Co. KG, Hamburg, Germany including Olympus Foundation, grants from Endoscopy Research Award 2012 of the German Society for Gastroenterology and Metabolism (DGVS) sponsored by Olympus Europe Foundation , grants from UEGW (United European Gastroenterology Week) 2010: Olympus Euro NOTES Research Found Program, during the conduct of the study; grants and personal fees from Olympus Europe SE & Co. KG, Hamburg, Germany, grants from Erbe Company Tübingen, Germany, grants from Karl Storz Company Tuttlingen, Germany, grants from Norgine Ltd Germany, Wettenberg, Germany, grants and personal fees from UniversaldX , Seville, Spain, personal fees from Amadix Ltd Madrid, Spain, grants from InterScope Med, Inc. Whitinsville, MA , USA, grants from Imevax Ltd Munich Germany, personal fees from Falk Foundation Freiburg, Germany, outside the submitted work; Dr. Schijven reports grants from Olympus BV, outside the submitted work.
Ethical Approval: The trial was approved by the institutional review board at each participating center. On-site data monitoring was provided by Clinical Trial Center North at the University Hospital Hamburg-Eppendorf and the European Clinical Research Infrastructure Network (ECRIN) for the initial analysis.
Keywords: achalasia, endoscopic myotomy, Heller myotomy, POEM, reflux
Suggested Citation: Suggested Citation