Personalized Peroral Endoscopic Myotomy for Achalasia

Study Overview
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Brief Summary
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Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.

Official Title
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Personalized Peroral Endoscopic Myotomy for Achalasia

Conditions
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Achalasia, Postoperative Complications

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 diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy Age over 18 years old Signed written informed consent Exclusion Criteria: Patients with previous surgery of the stomach or esophagus With known coagulopathy Active esophagitis,eosinophilic esophagitis or Barrett's esophagus Pregnancy Stricture of the esophagus Hiatal hernia > 2cm

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

| Intervention/Treatment |
| --- |
|Procedure: peroral endoscopic myotomy|A 3-cm incision is made into the mucosa after injection of saline and methylene blue. A submucosal tunnel is created from the mid-esophagus to the gastric cardia by a triangle-tip knife. The circular muscle fibers or full-thickness muscle are divided by the triangle-tip knife over a length of 6-20 cm on the esophagus, starting 3 cm below the initial mucosal incision, and extended 3-4cm onto the gastric cardia. The mucosal entry site is closed using standard endoscopic clips at last.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom relief | compare patients' symptoms before and after POEM at 1 month, 12 months. | 1-12months | 
| Lower esophageal sphincter pressure | compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months. | 1-12months | 
| improvement of esophageal barium | compare esophageal barium before and after POEM at 1 months,12 months | 1-12 months | 
| Postoperative complications | postoperative complications | 0-12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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achalasia, peroral endoscopic myotomy, LES pressure, postoperative complication, symptom relief, esophageal barium