Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

Study Overview
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Brief Summary
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Recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and Heller-Dor surgical myotomy. Endoscopic myotomy has been recently proposed in human patient in expert centers in Japan, US and Germany. In theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. Up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. The present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.

Official Title
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Peroral Endoscopic Myotomy for Primary Esophageal Achalasia

Conditions
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Primary 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: Patients of both sexes aged over 18 years old Patients who have signed the informed consent form before any study related procedure Primary achalasia of the cardia with Eckardt score > 3 Non sigmoid achalasia or S1 sigmoid type achalasia at barium meal Rx study ASA score (American Society of Anaesthesiologists) 1 or 2 Patients affiliated to a social security health system Exclusion Criteria: Patients with age less than 18 years old Patients without discernment with legal protection Patients who will not be able to abide with study follow-up as judged by the investigator Patients which cannot provide a written informed consent Patient refusing to participate in the study, without informed consent Pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum βHCG test Concomitant participation in other clinical trial S2 sigmoid type primitive achalasia of the cardia Pseudo-achalasia (esophageal carcinoma), History of Barrett's esophagus with or without dysplasia, malignant tumors of the esophagus History of esophageal strictures, systemic sclerosis History of esophageal varices History of endoscopic or surgical therapy of the esophageal achalasia History of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands) History of surgical interventions of the esophagus or stomach (fundoplication, Heller-Dor myotomy, gastric resections, vagotomy with or without gastric drainage) History of congenital of acquired coagulation anomalies: hemorrhagic diseases, hemostasis disturbances (TP < 60%, TCA > 40 seconds, platelets < 60000/mmc) ASA score (American Society of Anaesthesiologists) 3, 4, 5 or 6 Cancer, liver, respiratory, renal or heart failure which put the patients in the ASA risk group 3,4,5 or 6.

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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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: Single Arm<br>Peroral endoscopic myotomy | Procedure: Peroral endoscopic myotomy<br>* An endoscopy is performed under anesthesia with orotracheal intubation. After submucosal saline injection, an entry point in the submucosal space is created at 10 cm above the cardia. The endoscope will create a 12cm long tunnel in the caudal direction by submucosal dissection, stopping at 2cm below cardia. Then the muscular circular internal layer is sectioned on a 9cm length, starting 3 cm below the submucosal entry point. At the end the submucosal entry point is closed with metallic clips. A scanner is performed after the procedure so as to check the esophageal wall integrity. Alimentation is progressively introduced at day 1. This is a study of a procedure - peroral endoscopic myotomy (POEM). No new, unapproved device is used. All endoscopic tools are already approved for endoscopic submucosal dissection and associated complications (hemorrhage or perforation): dissection knifes, hot biopsy forceps, endoscopic metallic clips.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with clinically significant perforation | Clinically significant perforation is defined as an ensemble of procedural, clinical, biological and imaging parameters: perforation seen during procedure with placement of endoscopic metallic clips as closing method acute severe persistent pain, fever over 38.5°C, subcutaneous emphysema, pneumomediastinum, penumoperitoneum elevated white blood count with elevated neutrophils and elevated CRP, ascending values subcutaneous emphysema, pneumomediastinum, penumoperitoneum seen at imaging studies (day 1 CT scan) | Day 1 after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients with Eckardt score less than 3 | Eckardt score calculated at baseline and after procedure | at 3rd and 12th month after procedure | 
| significant variation of Eckardt score | Eckardt score calculated at baseline and after procedure | at baseline and at 1st, 3rd, 6th and 12th month after the procedure | 
| significant variation of GIQLI score | GIQLI score calculated at baseline and after procedure | at baseline and at 1st, 3rd, 6th and 12th month after the procedure | 
| significant variation of high resolution manometry parameters | high resolution manometry performed at baseline and at 3rd month after the procedure | at baseline and at 3rd month after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary esophageal achalasia, endoscopic myotomy, high resolution manometry