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

Primary Purpose

Achalasia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POEM
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Achalasia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

POEM procedure

Arm Description

Patients who underwent POEM

Outcomes

Primary Outcome Measures

Improvement in swallowing
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.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2015
Last Updated
June 26, 2020
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02482337
Brief Title
Per-Oral Endoscopic Myotomy for Esophageal Swallowing Disorders
Acronym
POEM
Official Title
Prospective Evaluation of Per-Oral Endoscopic Myotomy (POEM) of the Lower Esophageal Sphincter for the Treatment of Esophageal Swallowing Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
POEM procedure
Arm Type
Experimental
Arm Description
Patients who underwent POEM
Intervention Type
Procedure
Intervention Name(s)
POEM
Intervention Description
POEM procedure in the OR
Primary Outcome Measure Information:
Title
Improvement in swallowing
Description
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.
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Leeds, MD
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24362953
Citation
Pescarus R, Shlomovitz E, Swanstrom LL. Per-oral endoscopic myotomy (POEM) for esophageal achalasia. Curr Gastroenterol Rep. 2014 Jan;16(1):369. doi: 10.1007/s11894-013-0369-6.
Results Reference
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PubMed Identifier
17703382
Citation
Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy. 2007 Sep;39(9):761-4. doi: 10.1055/s-2007-966764.
Results Reference
background
Citation
Inoue H, Minami H, Satodate H, Kudo S. First clinical experience of submucosal endoscopic esophageal myotomy for esophageal achalasia with no skin incision. Gastrointestinal Endoscopy 69(5): AB122, 2009.
Results Reference
background
PubMed Identifier
11789770
Citation
Luketich JD, Fernando HC, Christie NA, Buenaventura PO, Keenan RJ, Ikramuddin S, Schauer PR. Outcomes after minimally invasive esophagomyotomy. Ann Thorac Surg. 2001 Dec;72(6):1909-12; discussion 1912-3. doi: 10.1016/s0003-4975(01)03127-7.
Results Reference
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Per-Oral Endoscopic Myotomy for Esophageal Swallowing Disorders

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