Endoscopic Peroral Myotomy for Treatment of Achalasia

Study Overview
=================
Brief Summary
-----------------
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.

Detailed Description
-----------------
This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center s 70 patients will be enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the Eckardt symptom score at 3 month after peroral endoscopic myotomy. Primary outcome: -Eckhard symptom score 3 month after therapy. Secondary outcomes: Lower esophageal sphincter pressure at 3 month after therapy. Reflux symptoms at 3 month after therapy. For this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophago-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion. A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.

Official Title
-----------------
Endoscopic Peroral Myotomy for Treatment of Achalasia: Multicenter Study

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: Endoscopic Peroral Myotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy which are consistent with the diagnosis persons of age > 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation Signed written informed consent. Exclusion Criteria: Patients with previous surgery of the stomach or esophagus Patients with known coagulopathy Previous achalasia-treatment with surgery Patients with liver cirrhosis and/or esophageal varices Active esophagitis Eosinophilic esophagitis Barrett's esophagus Pregnancy Stricture of the esophagus Malignant or premalignant esophageal lesion Candida esophagitis Hiatal hernia > 2cm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>Patients with achalasia who are designed to either have balloon dilatation or botulinum toxine injection, or to have surgical intervention (Heller myotomy) for therapy. Peroral endoscopic myotomy: A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips. | Procedure: Endoscopic Peroral Myotomy<br>* Endoscopic peroral myotomy: A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eckhard symptom score at 3 month after peroral endoscopic myotomy | Validated symptom score based on dysphagia, pain, regurgitation and weight loss | Score is evaluated at 3 month after peroral endoscopic myotomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower esophageal sphincter pressure | Manometry study | Lower esophageal sphincter pressure is determined by manometry at 3 month after peroral endoscopic myotomy | 
| Reflux Symptoms | Symptoms as reported by the patient | Reflux Symptoms are evaluated at 3 month after peroral endoscopic myotomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Achalasia, Heller myotomy, Dysphagia, Peroral Endoscopic Myotomy