Long-term results of the European Achalasia trial

A multicentre randomised Controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy

An Moonen, Vito Annese, Ann Belmans, Albert J. Bredenoord, Stanislas Bruley Des Varannes, Mario Costantini, Bertrand Dousset, J. Ignasi Elizalde, Uberto Fumagalli Romario, Marianne Gaudric, Antonio Merla, Andre J. Smout, Jan Tack, Giovanni Zaninotto, Olivier R. Busch, Guy E. Boeckxstaens

Research output: Contribution to journalArticle

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).

Original languageEnglish
Pages (from-to)732-739
Number of pages8
JournalGut
Volume65
Issue number5
DOIs
Publication statusPublished - May 1 2016

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Esophageal Achalasia
Multicenter Studies
Dilatation
Randomized Controlled Trials
Therapeutics
Esophageal Perforation
Lower Esophageal Sphincter
Random Allocation
Tears
Netherlands
Esophagus
Registries
Quality of Life
Pressure

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Moonen, A., Annese, V., Belmans, A., Bredenoord, A. J., Varannes, S. B. D., Costantini, M., ... Boeckxstaens, G. E. (2016). Long-term results of the European Achalasia trial: A multicentre randomised Controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy. Gut, 65(5), 732-739. https://doi.org/10.1136/gutjnl-2015-310602

Long-term results of the European Achalasia trial : A multicentre randomised Controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy. / Moonen, An; Annese, Vito; Belmans, Ann; Bredenoord, Albert J.; Varannes, Stanislas Bruley Des; Costantini, Mario; Dousset, Bertrand; Elizalde, J. Ignasi; Fumagalli Romario, Uberto; Gaudric, Marianne; Merla, Antonio; Smout, Andre J.; Tack, Jan; Zaninotto, Giovanni; Busch, Olivier R.; Boeckxstaens, Guy E.

In: Gut, Vol. 65, No. 5, 01.05.2016, p. 732-739.

Research output: Contribution to journalArticle

Moonen, A, Annese, V, Belmans, A, Bredenoord, AJ, Varannes, SBD, Costantini, M, Dousset, B, Elizalde, JI, Fumagalli Romario, U, Gaudric, M, Merla, A, Smout, AJ, Tack, J, Zaninotto, G, Busch, OR & Boeckxstaens, GE 2016, 'Long-term results of the European Achalasia trial: A multicentre randomised Controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy', Gut, vol. 65, no. 5, pp. 732-739. https://doi.org/10.1136/gutjnl-2015-310602
Moonen, An ; Annese, Vito ; Belmans, Ann ; Bredenoord, Albert J. ; Varannes, Stanislas Bruley Des ; Costantini, Mario ; Dousset, Bertrand ; Elizalde, J. Ignasi ; Fumagalli Romario, Uberto ; Gaudric, Marianne ; Merla, Antonio ; Smout, Andre J. ; Tack, Jan ; Zaninotto, Giovanni ; Busch, Olivier R. ; Boeckxstaens, Guy E. / Long-term results of the European Achalasia trial : A multicentre randomised Controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy. In: Gut. 2016 ; Vol. 65, No. 5. pp. 732-739.
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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).",
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AU - Annese, Vito

AU - Belmans, Ann

AU - Bredenoord, Albert J.

AU - Varannes, Stanislas Bruley Des

AU - Costantini, Mario

AU - Dousset, Bertrand

AU - Elizalde, J. Ignasi

AU - Fumagalli Romario, Uberto

AU - Gaudric, Marianne

AU - Merla, Antonio

AU - Smout, Andre J.

AU - Tack, Jan

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AU - Busch, Olivier R.

AU - Boeckxstaens, Guy E.

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N2 - 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).

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