Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial (POEM rcpmt)

• non-inferiority of POEM compared to LHM [ Time Frame: 3 months after procedure ] [ Designated as safety issue: No ]
  Primary outcome of the study ist the non-inferiority of POEM compared to LHM based on Lower esophageal sphincter pressure (LESP) on manometry after POEM compared to LHM
  
  

• Eckhard symptom scores [ Time Frame: before,and 3 and 6 months, 1,2,3 and 5 years past procedure ] [ Designated as safety issue: No ]
  Eckhard symptom scores will be assessed to evaluate individual therapy success
  
  
• reflux symptom assessment [ Time Frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure ] [ Designated as safety issue: No ]
  clinical DeMeester score will be assessed to compare therapeutic side effects
  
  
• Life Quality index [ Time Frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure ] [ Designated as safety issue: No ]
  Life quality assessment (gastrointestinal LQ index by Eypasch, Wood-Dauphinee and Troidl) for individual success evaluation
  
  
• pH metry [ Time Frame: 3 month after therapy ] [ Designated as safety issue: No ]
  pH metry data, probe or Bravo
  
  
• EGD findings [ Time Frame: 3 months and (optional) 2 and 5 years after therapy ] [ Designated as safety issue: No ]
  EGD findings to evaluate reflux effects after therapy
  
  
• complication rate [ Time Frame: Baseline to five years past procedure ] [ Designated as safety issue: Yes ]
  complication rate (Adverse Events(AE))
  
  

Peroral Endoscopic Myotomy myotomy (POEM) has been recently introduced for treatment of achalasia, based on technical developments from NOTES (natural orifice translumenal surgery). The technique uses a submucosal esophageal tunnel through which a distal esophageal myotomy down to the proximal stomach is performed. Single center studies demonstrate promising short-term results of POEM for the treatment of achalasia, leading us to hope for a similar success rate along with reduced patient discomfort. For POEM to be integrated inot clinical routine, comparative data regarding safety and efficacy are necessary. This study intends to investigate the feasibility, safety and efficacy of Peroral Endoscopic Myotomy (POEM)for the treatment of achalasia compared to laparoscopic surgical therapy (laparoscopic Heller Myotomy)in a non-inferiority design.

Patients with symptomatic achalasia and medical indication for interventional therapy will be randomized to either POEM therapy or standard laparoscopic Heller myotomy (with anti-reflux procedure)(LHM). They will be followed up closely in a defined time pattern evolving individual life quality and achalasia scores as well as clinical scores and diagnostics over a period of 5 years.