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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
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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
Esophageal Achalasia Procedure: POEM

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention
Patients undergoing POEM for spastic esophageal disorders such as achalasia at the University Health Network, Toronto, Canada
Procedure: POEM
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.
Other Names:
  • Peroral endoscopic myotomy
  • Endoscopic myotomy

Primary Outcome Measures :
  1. Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Surgical complications [ Time Frame: 30 days ]
    Based on Clavien-Dindo classification of surgical complications

  2. LES pressure (according to manometry) [ Time Frame: 6 months ]
    Lower esophageal sphincter (LES) pressure according to manometry pre and post intervention

  3. pH test (pH level in esophagus) [ Time Frame: 6 months ]
    pre and post intervention

  4. Diameter of the esophageal body [ Time Frame: 1 year ]
    Change in diameter of the esophageal body according to upper endoscopy findings

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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, MD 416-340-3287 eran.shlomovitz@uhn.ca
Contact: Allan Okrainec, MD 416-603-5224 allan.okrainec@uhn.ca

Canada, Ontario
Toronto General Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eran Shlomovitz, MD    416-340-3287    eran.shlomovitz@uhn.ca   
Principal Investigator: Eran Shlomovitz, MD         
Sub-Investigator: Allan Okrainec, MD         
Sub-Investigator: Gail Darling, MD         
Sub-Investigator: David Urbach, MD         
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Eran Shlomovitz, MD University Health Network, Toronto


Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02425033     History of Changes
Other Study ID Numbers: 14-8327
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Keywords provided by University Health Network, Toronto:
Minimally invasive surgery
Spastic esophageal disorders

Additional relevant MeSH terms:
Esophageal Achalasia
Muscle Spasticity
Esophageal Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases