Per-Oral Endoscopic Myotomy for Esophageal Swallowing Disorders (POEM)

June 26, 2020 updated by: Baylor Research Institute

Prospective Evaluation of Per-Oral Endoscopic Myotomy (POEM) of the Lower Esophageal Sphincter for the Treatment of Esophageal Swallowing Disorders

The purpose of this study is to show that the Per-Oral Endoscopic Myotomy (POEM) procedure is an effective treatment for people with achalasia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Currently the most commonly performed definitive treatment for symptomatic esophago-gastric junction outflow obstruction is a laparoscopic esophageal myotomy (LEM). In this procedure the outer longitudinal and inner circular muscle fibers of the distal esophagus and proximal stomach are divided, releasing the spasm and resulting in an open lumen. Although this procedure is effective in relieving troubles swallowing and in improving esophageal emptying, it is often accompanied by the development of GERD (as the muscle division results in incompetence of the antireflux barrier, the lower esophageal sphincter). For this reason a laparoscopic esophageal myotomy is most often accompanied by a fundoplication, in which part of the fundus of the stomach is folded around the distal esophagus and sutured in place, recreating a flap-valve mechanism. (It is best to perform this at the time of the laparoscopic myotomy as reoperation in that area is difficult). The fundoplication however may be imperfect, and may result in some degree of outflow obstruction itself or fail to control reflux. LEM results in 80% to 90% global patient satisfaction; but 10-20% continue to experience moderate dysphagia and 10-35% will have GERD by esophageal pH testing.

Others have evaluated the possibility of surgically dividing the muscle fibers from within the esophagus, using an endoscope rather than a laparoscope, in an animal model. The first human experience was reported in Japan using a per-oral endoscope to (a) incise the mucosa in the proximal esophagus as an entry point, (b) create a submucosal tunnel downwards, (c) perform an esophageal myotomy of the distal esophageal circular muscle, and (d) close the mucosal entry site with clips. The creation of the submucosal tunnel for some distance before the myotomy is a safety measure, so that should the mucosal closure fail, native tissues will appose and help seal any leak (rather like the Z-entry for a thoracentesis). Subsequent to this initial report, multiple single-arm studies have reported that the technique is safe and is associated with excellent medium-term relief of dysphagia..

In the POEM technique no fundoplication is performed. By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer could be easily visualized and in contrast to conventional laparoscopic esophageal myotomy, the authors described the division of only this inner circular esophageal muscle layer leaving the outer longitudinal muscle layer intact. The distal esophagus is exposed in LEM, hence disrupting the attachments to the diaphragm. These attachments contribute to the overall antireflux mechanism. It is hypothesized that by only dividing the inner circular muscle, and not disrupting the contribution of the outer longitudinal muscle or the diaphragmatic attachments to the antireflux mechanism, POEM may not have the same potential for reflux as a LEM. If this is the case then an antireflux procedure may not be needed after the POEM procedure.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Locations

    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

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:

  • Patient with symptomatic achalasia or EGJ outflow obstruction with a motility study, esophagram, and EGD consistent with EGJ outflow obstruction.
  • Medical indication for surgical myotomy.
  • Ability to undergo general anesthesia
  • Age > 18 yrs. of age and <85 yrs. of age with ability to give informed consent
  • Candidate for laparoscopic esophageal myotomy.

Exclusion Criteria:

  • Previous chest radiotherapy.
  • Eosinophilic esophagitis
  • Barrett's esophagus
  • Stricture of esophagus
  • Malignant or premalignant esophageal lesion
  • Contraindications for EGD.
  • Unable to provide informed consent.
  • Pregnancy

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POEM procedure
Patients who underwent POEM
POEM procedure in the OR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in swallowing
Time Frame: 6 months after surgery
Outcome measure will be assessed by a questionnaire based on the patient's ability to swallow, by radiographic study, upper gastrointestinal endoscopy and ambulatory reflux testing.
6 months after surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Steven Leeds, MD, Baylor Health Care System

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.

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

June 1, 2014

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 7, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

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.

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