We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02482337
Recruitment Status : Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : January 19, 2018
Information provided by (Responsible Party):
Baylor Research Institute

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

Condition or disease Intervention/treatment
Achalasia Procedure: POEM

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Evaluation of Per-Oral Endoscopic Myotomy (POEM) of the Lower Esophageal Sphincter for the Treatment of Esophageal Swallowing Disorders
Study Start Date : June 2014
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: POEM procedure
Patients who underwent POEM
Procedure: POEM
POEM procedure in the OR

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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): NCT02482337

United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Principal Investigator: Steven Leeds, MD Baylor Health Care System

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02482337     History of Changes
Other Study ID Numbers: 014-103
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases