Prospective Study on the Feasibility and Results of POEM in Idiopathic Achalasia

Study Overview
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Brief Summary
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Treatment options for achalasia include endoscopic dilations and surgical myotomy. Recently the POEM (Per oral endoscopic myotoymy) technique has been described. Patients undergo myotomy under endoscopic control. It has advantage over endoscopic dilation since myotomy is performed, and has advantage over surgery because it is performed endoscopically, thus is less invasive. One potential disadvantage in respect to surgery may be that it may determine higher rates of post-operative reflux. The purpose of this study is to prospectively assess the feasibility of PEOM in our Center with the new hybrid knife, and clinical results at 1, 3 and 12 months. This is a prospective, phase II study. Ten patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will be included for the POEM procedure. This study will last about 2 years. The aim is the feasibility, security and success rate of POEM for achalasia. Patients will be followed for at least one year.

Official Title
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Prospective Study on the Feasibility and Results of the Treatment of Idiopathic Achalasia With the POEM (Per Oral Endoscopic Myotomy) Technique

Conditions
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Achalasia

Intervention / Treatment
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* Device: Hybrid Knife


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years Manometric diagnosis of achalasia Eckardt score more than 3 Informed consent Exclusion Criteria: Increased surgical risk for important comorbidities, Pseudoachalasia Mega-esophagus (more than 7 cm) and or sigmoid esophagus, Previous esophageal or gastric surgery (with the exception of gastric perforation) Inability of completing the questionnarie Inability to keep a commitment for follow-up Esophageal diverticulum

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Achalasia<br>Patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will undergo POEM with the hybrid knife. | Device: Hybrid Knife<br>* POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Percentage of patients with successful POEM | 24 months | 
| Clinical Success | A reduction of 2 or more points in the Eckardt score, that determines a score of 3 or more in 24 months. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life as measured by questionnaires (SF36 and l'EORTC QLQ-OES24) that will be administered to the patients at 3 and 12 months. | 24 months | 
| Adverse events | Post-operative adverse events (perforation, bleeding, infection, aspiration, etc) | 24 months | 
| Reflux disease | Reflux disase as diagnosed clinically (HRQL questionnarie) or by 24-hour pH-metry | 24 months | 
| Treatment failure | Percentages of patients in which other interventions for dysphagia are required after the first POEM. | 24 months | 
| Efficacy | Basal and post-treatment pressure of the lower esophageal sphincter, as measured by manometry and esophageal follow-through. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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achalasia, per oral endoscopic myotoymy, endoscopy