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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
RECRUITINGEffectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire)
Time frame: 1 year
Surgical complications
Based on Clavien-Dindo classification of surgical complications
Time frame: 30 days
LES pressure (according to manometry)
Lower esophageal sphincter (LES) pressure according to manometry pre and post intervention
Time frame: 6 months
pH test (pH level in esophagus)
pre and post intervention
Time frame: 6 months
Diameter of the esophageal body
Change in diameter of the esophageal body according to upper endoscopy findings
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.