POEM for Spastic Esophageal Disorders

Study Overview
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Brief Summary
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This study evaluates the efficacy and safety of the Per-Oral Endoscopic Myotomy (POEM) technique for lower esophageal sphincter myotomy in patients suffering from spastic esophageal disorders such as achalasia at a Canadian institution. The investigators hypothesize that POEM is a safe and effective technique for the surgical management of such disorders at our institution.

Detailed Description
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Standard surgical care for spastic esophageal disorders such as achalasia includes a procedure called Heller myotomy. The treatment in our study, called endoscopic myotomy (also known as peroral endoscopic myotomy - POEM) is different from standard surgery (Heller myotomy) because it is less invasive, is less likely to cause reflux, and usually requires shorter operative times with less loss of blood during the surgery. Although POEM has been adopted worldwide and has proven to be successful, the experience in Canada is very limited to date.

Official Title
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Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter in Patients With Spastic Esophageal Disorders Such as Achalasia

Conditions
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Esophageal Achalasia

Intervention / Treatment
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* Procedure: POEM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic achalasia or similar spastic esophageal disorder and pre-op barium swallow, manometry, and esophagogastroduodenoscopy being consistent with the diagnosis Ability to undergo general anesthesia Age > 18 yrs and < 85 yrs. of age Ability to give informed consent Candidate for elective Heller myotomy Exclusion Criteria: Contraindications for esophagogastroduodenoscopy Contraindications for elective Heller myotomy BMI > 45 Currently pregnant Refusing to participate in the study or without informed consent Concomitant participation in other clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Intervention<br>Patients undergoing POEM for spastic esophageal disorders such as achalasia at the University Health Network, Toronto, Canada | Procedure: POEM<br>* Under general anesthesia, patient undergoes upper endoscopy and a small longitudinal submucosal incision is created and a dilating balloon is inserted submucosally via the created incision. The balloon is slightly inflated to allow entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via endoscopic or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified using endoscopic landmarks. Using a dissection knife, the clearly visible circular muscles are divided. The longitudinal layer is left intact and the mucosal entry is closed.<br>* Other names: Endoscopic myotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Based on Clavien-Dindo classification of surgical complications | 30 days | 
| LES pressure (according to manometry) | Lower esophageal sphincter (LES) pressure according to manometry pre and post intervention | 6 months | 
| pH test (pH level in esophagus) | pre and post intervention | 6 months | 
| Diameter of the esophageal body | Change in diameter of the esophageal body according to upper endoscopy findings | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POEM, Minimally invasive surgery, Achalasia, Spastic esophageal disorders