Boeckxstaens, Guy;
Elsen, Stefanie;
Belmans, Ann;
Annese, Vito;
Bredenoord, Albert J;
Busch, Olivier R;
Costantini, Mario;
Fumagalli, Uberto;
Smout, André J P M;
Tack, Jan;
Vanuytsel, Tim;
Zaninotto, Giovanni;
Salvador, Renato
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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Media type:
E-Article
Title:
10-year follow-up results of the European Achalasia Trial: a multicentre randomised controlled trial comparing pneumatic dilation with laparoscopic Heller myotomy
Contributor:
Boeckxstaens, Guy;
Elsen, Stefanie;
Belmans, Ann;
Annese, Vito;
Bredenoord, Albert J;
Busch, Olivier R;
Costantini, Mario;
Fumagalli, Uberto;
Smout, André J P M;
Tack, Jan;
Vanuytsel, Tim;
Zaninotto, Giovanni;
Salvador, Renato
Description:
<jats:sec><jats:title>Objective</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>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<jats:underline><</jats:underline>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>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.</jats:p></jats:sec>