Per-Oral Endoscopic Myotomy for Esophageal Swallowing Disorders

NCT02482337 | Terminated DMC

• 1 other identifier: 014-103
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after surgery

Study Arms (1)

POEM procedure

EXPERIMENTAL

Patients who underwent POEM

Procedure: POEM

Interventions

POEM PROCEDURE

POEM procedure in the OR

POEM procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (4)

• 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.

  PMID: 24362953 BACKGROUND

• 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.

  PMID: 17703382 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11789770 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Steven Leeds, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: June 26, 2015
• Study Start: June 1, 2014
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (1)