NCT02018705

Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia

Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia, a Retrospective Multicenter Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM). Studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, long-term comparative data with LHM is required. Therefore,the intention for this study is to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.

Detailed description

Achalasia is a neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus. The standard surgical treatment for achalasia is laparoscopic Heller Myotomy (LHM). A recent meta-analysis of 105 studies reporting on 7855 patients demonstrated that laparoscopic Heller myotomy is the most effective and long-lasting therapy for achalasia. Superior to Endoscopic balloon dilatation or Botulinumtoxin injection LHM has a one year therapeutic efficacy in approximately 90% of patients. Recently an endoscopic technique emulating the principles of LHM was developed. This technique of a purely endoscopic myotomy has been demonstrated by Pasricha et al. in animal experiments and Inoue et al. reported the first clinical study. Other pilot studies and a larger international multi-center trial have replicated promising results for POEM. Uncontrolled studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, however, comparative data with LHM is required. Our study group intends to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.

Conditions

• Comparison of Short- Term Success Rates of POEM With LHM
• Comparison of Long-term Success Rates of POEM With LHM

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-12-23
• Last updated: 2019-06-07

Locations

5 sites across 4 countries: Denmark, Germany, Netherlands, Switzerland