POEM for Spastic Esophageal Disorders

October 27, 2016 updated by: University Health Network, Toronto

Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter in Patients With Spastic Esophageal Disorders Such as Achalasia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital, University Health Network
        • Contact:
        • Principal Investigator:
          • Eran Shlomovitz, MD
        • Sub-Investigator:
          • Allan Okrainec, MD
        • Sub-Investigator:
          • Gail Darling, MD
        • Sub-Investigator:
          • David Urbach, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Eran Shlomovitz, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-8327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Achalasia

Clinical Trials on POEM

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe