POEM for Spastic Esophageal Disorders
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|ClinicalTrials.gov Identifier: NCT02425033|
Recruitment Status : Recruiting
First Posted : April 23, 2015
Last Update Posted : October 31, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Achalasia||Procedure: POEM||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter in Patients With Spastic Esophageal Disorders Such as Achalasia|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Patients undergoing POEM for spastic esophageal disorders such as achalasia at the University Health Network, Toronto, Canada
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.
- Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire) [ Time Frame: 1 year ]
- Surgical complications [ Time Frame: 30 days ]Based on Clavien-Dindo classification of surgical complications
- LES pressure (according to manometry) [ Time Frame: 6 months ]Lower esophageal sphincter (LES) pressure according to manometry pre and post intervention
- pH test (pH level in esophagus) [ Time Frame: 6 months ]pre and post intervention
- Diameter of the esophageal body [ Time Frame: 1 year ]Change in diameter of the esophageal body according to upper endoscopy findings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425033
|Contact: Eran Shlomovitz, MDfirstname.lastname@example.org|
|Contact: Allan Okrainec, MDemail@example.com|
|Toronto General Hospital, University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Eran Shlomovitz, MD 416-340-3287 firstname.lastname@example.org|
|Principal Investigator: Eran Shlomovitz, MD|
|Sub-Investigator: Allan Okrainec, MD|
|Sub-Investigator: Gail Darling, MD|
|Sub-Investigator: David Urbach, MD|
|Principal Investigator:||Eran Shlomovitz, MD||University Health Network, Toronto|