title: Long-term results of the European achalasia trial: a multicentre randomised controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy.
abstract: OBJECTIVE
  Achalasia is a chronic motility disorder of the oesophagus for which laparoscopic Heller myotomy (LHM) and endoscopic pneumodilation (PD) are the most commonly used treatments. However, prospective data comparing their long-term efficacy is lacking.
  
  
  METHODS
  201 newly diagnosed patients with achalasia were randomly assigned to PD (n=96) or LHM (n=105). Before randomisation, symptoms were assessed using the Eckardt score, functional test were performed and quality of life was assessed. The primary outcome was therapeutic success (presence of Eckardt score ≤3) at the yearly follow-up assessment. The secondary outcomes included the need for re-treatment, lower oesophageal sphincter pressure, oesophageal emptying and the rate of complications.
  
  
  RESULTS
  In the full analysis set, there was no significant difference in success rate between the two treatments with 84% and 82% success after 5 years for LHM and PD, respectively (p=0.92, log-rank test). Similar results were obtained in the per-protocol analysis (5-year success rates: 82% for LHM vs. 91% for PD, p=0.08, log-rank test). After 5 years, no differences in secondary outcome parameter were observed. Redilation was performed in 24 (25%) of PD patients. Five oesophageal perforations occurred during PD (5%) while 12 mucosal tears (11%) occurred during LHM.
  
  
  CONCLUSIONS
  After at least 5 years of follow-up, PD and LHM have a comparable success rate with no differences in oesophageal function and emptying. However, 25% of PD patients require redilation during follow-up. Based on these data, we conclude that either treatment can be proposed as initial treatment for achalasia.
  
  
  BACKGROUND
  Netherlands trial register (NTR37) and Current Controlled Trials registry (ISRCTN56304564).
authors.affiliation: Department of Gastroenterology, Catholic University of Leuven, Leuven, Belgium.
authors.forename: An
authors.initials: A
authors.lastname: Moonen
authors.affiliation: Head of Gastroenterology, Department of Emergency, AOU Careggi, Florence, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.affiliation: Interuniversity Centre for Biostatistics and Statistical Bioinformatics, KU, Leuven, Belgium.
authors.forename: Ann
authors.initials: A
authors.lastname: Belmans
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Bredenoord
authors.affiliation: Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France.
authors.forename: Stanislas
authors.initials: S
authors.lastname: Bruley des Varannes
authors.affiliation: Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Costantini
authors.affiliation: Department of GI and Endocrine Surgery, Hôpital Cochin, Paris, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Dousset
authors.affiliation: Department of Gastroenterology, Hospital Clínic, CIBERehd, IDIBAPS, University of Barcelona, Barcelona, Spain.
authors.forename: J I
authors.initials: JI
authors.lastname: Elizalde
authors.affiliation: Upper GI Surgery, Humanitas Clinical and Research Hospital, Rozzano, Italy.
authors.forename: Uberto
authors.initials: U
authors.lastname: Fumagalli
authors.affiliation: Department of Gastroenterology, Hopital Cochin, Paris, France.
authors.forename: Marianne
authors.initials: M
authors.lastname: Gaudric
authors.affiliation: Division of Gastroenterology, IRCCS, "Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Merla
authors.affiliation: Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Andre J
authors.initials: AJ
authors.lastname: Smout
authors.affiliation: Department of Gastroenterology, Catholic University of Leuven, Leuven, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Tack
authors.affiliation: Department of Academic Surgery, St Mary's Hospital, Imperial College, London, UK.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Zaninotto
authors.affiliation: Gastrointestinal Surgery, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Olivier R
authors.initials: OR
authors.lastname: Busch
authors.affiliation: Department of Gastroenterology, Catholic University of Leuven, Leuven, Belgium.
authors.forename: Guy E
authors.initials: GE
authors.lastname: Boeckxstaens
mesh_terms: D000328:Adult; D004106:Dilatation; D004931:Esophageal Achalasia / Q000628:therapy*; D004945:Esophagoscopy; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors
keywords: ACHALASIA