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  • 10-year follow-up results of the European Achalasia Trial: a multicentre randomised controlled trial comparing pneumatic dilation with laparoscopic Heller myotomy

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Oesophagus
Original research
10-year follow-up results of the European Achalasia Trial: a multicentre randomised controlled trial comparing pneumatic dilation with laparoscopic Heller myotomy
  1. Guy Boeckxstaens1,
  2. Stefanie Elsen1,
  3. Ann Belmans2,
  4. Vito Annese3,
  5. Albert J Bredenoord4,
  6. Olivier R Busch5,
  7. Mario Costantini6,
  8. Uberto Fumagalli7,
  9. André J P M Smout4,
  10. Jan Tack1,
  11. Tim Vanuytsel1,
  12. Giovanni Zaninotto8,
  13. Renato Salvador6
  1. 1 Department of Gastroenterology, Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium
  2. 2 Interuniversity Centre for Biostatistics and Statistical Bioinformatics, KU Leuven, Leuven, Belgium
  3. 3 Department of Gastroenterology, IRCCS San Donato Policlinic, San Donato Milanese, Vita-Salute San Raffaele University, Milano, Italy
  4. 4 Department of Gastroenterology and Hepatology, Amsterdam UMC Locatie Meibergdreef, Amsterdam, The Netherlands
  5. 5 Department of Surgery, Amsterdam UMC Locatie Meibergdreef, Amsterdam, The Netherlands
  6. 6 Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padova, Italy
  7. 7 Department of Digestive Surgery, European Institute of Oncology - IRCCS, Milano, Italy
  8. 8 Department of Academic Surgery, St Mary's Hospital, Imperial College London, London, UK
  1. Correspondence to Professor Guy Boeckxstaens, Department of Gastroenterology, Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Flanders, Belgium; guy.boeckxstaens{at}kuleuven.be

Abstract

Objective As achalasia is a chronic disorder, long-term follow-up data comparing different treatments are essential to select optimal clinical management. Here, we report on the 10-year follow-up of the European Achalasia Trial comparing endoscopic pneumodilation (PD) with laparoscopic Heller myotomy (LHM).

Design A total of 201 newly diagnosed patients with achalasia were randomised to either a series of PDs (n=96) or LHM (n=105). Patients completed symptom (Eckardt score) and quality-of-life questionnaires, underwent functional tests and upper endoscopy. Primary outcome was therapeutic success defined as Eckardt score <3 at yearly follow-up. Secondary outcomes were the need for retreatment, lower oesophageal sphincter pressure, oesophageal emptying, gastro-oesophageal reflux and the rate of complications.

Results After 10 years of follow-up, LHM (n=40) and PD (n=36) were equally effective in both the full analysis set (74% vs 74%, p=0.84) and the per protocol set (74% vs 86%, respectively, p=0.07). Subgroup analysis revealed that PD was superior to LHM for type 2 achalasia (p=0.03) while there was a trend, although not significant (p=0.05), that LHM performed better for type 3 achalasia. Barium column height after 5 min at timed barium oesophagram was significantly higher for patients treated with PD compared with LHM, while other parameters, including gastro-oesophageal reflux, were not different.

Conclusions PD and LHM are equally effective even after 10 years of follow-up with limited risk to develop gastro-oesophageal reflux. Based on these data, we conclude that PD and LHM can both be proposed as initial treatment of achalasia.

  • achalasia
  • laparoscopic surgery
  • endoscopic procedures

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

https://doi.org/10.1136/gutjnl-2023-331374

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Contributors This investigator initiated trial was conceived by GB. GB, ORB, MC, AJPMS, JT and GZ have participated in the initial design of the study during investigator meetings. GB, VA, AJB, ORB, MC, UF, AJPMS, JT, TV, GZ and RS included and/or treated patients for the clinical trial. The data were analysed by SE and GB with the assistance of AB, who is a statistician. GB wrote the first and final versions of the manuscript and, in consultation with the other authors (SE, AB, VA, AJB, ORB, MC, UF, AJPMS, JT, TV, GZ, RS), made the decision to submit the manuscript for publication. No commercial entity had any role in the study. All the authors vouch for the completeness and accuracy of the data. GB is responsible for the overall content as guarantor.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests GEB is Associate Editor of this journal.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.