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

Study Overview
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Brief Summary
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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
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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.

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

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic achalasia and pre-op barium swallow, manometry and oesophago-gastro-duodenoscopy which have been consistent with the diagnosis Age > 18 years with medical indication for interventional achalasia treatment Availability of Eckardt score at baseline and 12 months after initial treatment 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POEM<br>group of Achalasia patients treated with POEM (peroral endoscopic myotomy) | |
| LHM<br>group of Achalasia patients treated with LHM (laparoscopic Heller myotomy)(+ fundoplication) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment success | treatment success is defined as an Eckardt Score </=3 | 1 year after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure related adverse events | retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure | 3 months after treatment | 
| lower esophageal sphincter pressure (LESP) | retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure | 3 months after treatment | 
| symptomatic reflux and use of antacid medication | retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure | 3 months after treatment | 
| procedure related adverse events | retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure | 12 months after treatment | 
| lower esophageal sphincter pressure (LESP) | retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure | 12 months after treatment | 
| symptomatic reflux and use of antacid medication | retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure | 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LHM, POEM, Achalasia treatment, LES sphincter myotomy