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

贲门失弛缓症 医学 肌切开术 回流 内科学 食管 球囊扩张 外科 内窥镜检查 海勒肌切开术 高分辨率测压 临床试验 食管括约肌 格尔德 食道疾病 胃肠病学 气球 疾病
作者
Guy E. Boeckxstaens,Stefanie Elsen,Ann Belmans,Vito Annese,Albert J. Bredenoord,Olivier R. Busch,Mario Costantini,Uberto Fumagalli,A. J. P. M. Smout,Jan Tack,Tim Vanuytsel,Giovanni Zaninotto,Renato Salvador
出处
期刊:Gut [BMJ]
卷期号:: gutjnl-331374
标识
DOI:10.1136/gutjnl-2023-331374
摘要

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).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.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.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.
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