POEM for Spastic Esophageal Disorders
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About
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.
Full description
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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Eran Shlomovitz, MD; Allan Okrainec, MD
Data sourced from clinicaltrials.gov
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