Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach

Study Overview
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Brief Summary
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Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique allowing to cure this pathology. In this study, investigators are using a new endoluminal technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy). This technique does not require any cutaneous incision. Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context, the introduction of the POEM technique seems to be an original approach and a natural evolution to a new generation of surgical endoscopy.

Official Title
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Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach

Conditions
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Esophagus Achalasia

Intervention / Treatment
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* Procedure: Peroral endoscopic myotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Esophagus achalasia Confirmed by esophageal manometry Requiring surgical care No contraindication to general anesthesia BMI under 40 kg/m² Ability to give an informed consent Candidate to elective Heller's myotomy Affiliation to a social security system Signed and informed consent Exclusion Criteria: Advanced esophageal dilatation (sigmoid megaesophagus) Previous mediastinal or esophageal surgery Contraindication to esophagogastroduodenoscopy (EGD) Contraindication to general anesthesia BMI above 40 kg/m² Infectious esophagitis (e.g. candidiasis) Psychiatric context unsuitable with an experimental protocol Allergy to beta-lactam Contraindication to endoscopy (esophageal stenosis, suspicion of digestive perforation, state of shock, severe anemia, cardiorespiratory failure or severe metabolic disorders) Contraindication to monitored pneumoperitoneum (cardiorespiratory failure or severe metabolic disorders) Inability to give an informed consent (emergency situations, misunderstanding…) Patient in custody Patient under guardianship Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peroral endoscopic myotomy<br> | Procedure: Peroral endoscopic myotomy<br>* Peroral endoscopic myotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety assessment will be based on the reading of all surgical intraoperative complications |  | 6 months post surgery |