POEM for Spastic Esophageal Disorders

Not Applicable

• Conditions: Esophageal Achalasia
• Interventions: Procedure: POEM

• Registration Number: NCT02425033
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-23
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	POEM	Patients undergoing POEM for spastic esophageal disorders such as achalasia at the University Health Network, Toronto, Canada

Primary Outcome Measures

Name	Time	Method
Effectiveness of intervention (Symptom severity relief according to pre- and post-operative quality of life questionnaire)	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Toronto General Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada