Article Text

other Versions

PDF
Original article
Long-term results of the European achalasia trial: a multicentre randomised controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy
  1. An Moonen1,
  2. Vito Annese2,
  3. Ann Belmans3,
  4. Albert J Bredenoord4,
  5. Stanislas Bruley des Varannes5,
  6. Mario Costantini6,
  7. Bertrand Dousset7,
  8. J I Elizalde8,
  9. Uberto Fumagalli9,
  10. Marianne Gaudric10,
  11. Antonio Merla11,
  12. Andre J Smout4,
  13. Jan Tack1,
  14. Giovanni Zaninotto12,
  15. Olivier R Busch13,
  16. Guy E Boeckxstaens1
  1. 1Department of Gastroenterology, Catholic University of Leuven, Leuven, Belgium
  2. 2Head of Gastroenterology, Department of Emergency, AOU Careggi, Florence, Italy
  3. 3Interuniversity Centre for Biostatistics and Statistical Bioinformatics, KU, Leuven, Belgium
  4. 4Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands
  5. 5Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes, France
  6. 6Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy
  7. 7Department of GI and Endocrine Surgery, Hôpital Cochin, Paris, France
  8. 8Department of Gastroenterology, Hospital Clínic, CIBERehd, IDIBAPS, University of Barcelona, Barcelona, Spain
  9. 9Upper GI Surgery, Humanitas Clinical and Research Hospital, Rozzano, Italy
  10. 10Department of Gastroenterology, Hopital Cochin, Paris, France
  11. 11Division of Gastroenterology, IRCCS, “Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
  12. 12Department of Academic Surgery, St Mary's Hospital, Imperial College, London, UK
  13. 13Gastrointestinal Surgery, Academic Medical Center, Amsterdam, The Netherlands
  1. Correspondence to Professor G E Boeckxstaens, Department of Gastroenterology, Translational Research Center for Gastrointestinal Disorders (TARGID), University Hospital Leuven, Catholic University Leuven, O&N1, Herestraat 49, Box 701, Leuven 3000, Belgium; Guy.boeckxstaens{at}med.kuleuven.be

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.

Design 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.

Trial registration numbers Netherlands trial register (NTR37) and Current Controlled Trials registry (ISRCTN56304564).

  • ACHALASIA

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles