Endoscopic Peroral Myotomy for Treatment of Achalasia

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

Detailed Description
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This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe. 16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy. Primary outcome: -eckhardt 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, esophagal-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. An electric generator 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
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Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study

Conditions
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Achalasia

Intervention / Treatment
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* Other: Peroral Endoscopic Myotomy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy 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
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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: Peroral Endoscopic Myotomy<br>Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxin injection, or to have surgical intervention (Heller myotomy)for treatment | Other: Peroral Endoscopic Myotomy<br>* 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. An electric generator 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3 | eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure | esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure | manometry at 3 month after therapy | 
| Number of Participants With Reflux Symptoms | Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment | during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment | 
| Number of Participants With Procedure-related Adverse Events | procedure-related adverse events per protocol | procedure to 3 months post procedure | 
| Medication 3 Months After POEM | proton pump inhibitor (PPI) use at 3 months after POEM procedure | 3 months | 
| Duration Time Procedure | duration time of POEM procedures in minutes | procedure | 
| Days Duration Hospitalization | participants were followed for the duration of hospital stay, an average of 4 days | days of hospitalization for POEM procedure, an average of 4 days | 
| cm Myotomy Length | myotomy length in cm | POEM procedure | 
| Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment | eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals. | 3 months after treatment | 

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