Endoscopic versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial

Study Objective

Achalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus. Clinical symptoms include dysphagia, regurgitation, and chest pain. Endoscopic therapies for achalasia consist of balloon dilatation (EBD) and botulinum toxin injection (EBTI). The surgical alternative is Heller Myotomy; surgery is nowadays mostly performed via the laparoscopic approach. Surgical therapy demonstrated superior treatment efficacy compared to EBD and EBTI in a large meta-analysis; it achieves a sustained therapeutic effect in approximately 90% of patients (respective rates are 70% for EBD, 40% for EBTI). Recently, an endoscopic means to perform myotomy via a submucosal tunnel has been developed, namely PerOral Endoscopic Myotomy (POEM).

This technique has initially been reported by Pasricha in experimental studies, and Inoue et al. reported the first human experience. Uncontrolled studies have indicated a symptomatic success rate of >90% for POEM in short term follow-ups.

The aim of this randomized study is to compare short and long-term efficacy of POEM with LHM using the Eckardt symptom score as primary outcome.

At present, POEM has the potential to be the first scarless flexible endosurgical intervention to become an established clinical treatment. For this to happen, however, comparative data with established treatments such as surgical myotomy regarding safety and efficacy are necessary. The objective of the study is to compare safety and long-term efficacy of POEM to laparoscopic Heller myotomy, the current gold-standard.

The sponsor of the study is the University Hamburg-Eppendorf and the study will take place in about 17 centres across several countries: Germany, Belgium, The Netherlands, Sweden, Switzerland, Austria, Denmark, Italy, Czech Republic, Canada & USA. The coordinating investigator for the Project is Prof. Dr. Thomas Rösch (Department of Interdisciplinary Endoscopy, University Hamburg-Eppendorf)

Participation conditions

Inclusion criteria

•Patients with symptomatic achalasia with an Eckardt score of > 3 and pre-op barium swallow, manometry and esophago-gastroduodenoscopy which are consistent with the diagnosis
•Patients are classified as achalasia type I-III according to Pandolfino
•Age > 18 years with medical indication for surgical myotomy or EBD
•Signed written informed consent.

Exclusion criteria

•Patients with previous surgery of the stomach or esophagus
•Patients with known coagulopathy
•Previous surgical achalasia treatment
•Patients with liver cirrhosis and/or esophageal varices
•Active esophagitis
•Eosinophilic esophagitis
•Barrett’s esophagus
•Pregnancy
•Stricture of the esophagus
•Malignant or premalignant esophageal lesion
•Severe Candida esophagitis
•Hiatal hernia > 1cm
•Extensive, tortuous dilatation (>7cm luminal diameter, S shape) of the esophagus
•Advanced malignant tumor with prognosis < 2 years

Centers managed by the CIEC:

Belgium: Universitair Ziekenhuis Leuven (UZ Leuven), Leuven