Endolumenal Partial Myotomy for Esophageal Motility Disorders

Endolumenal Partial Myotomy for Esophageal Motility Disorders
This study is currently recruiting participants.
Verified November 2010 by The Oregon Clinic

First Received on February 23, 2011.  
Last Updated on February 25, 2011  
History of Changes
Sponsor: The Oregon Clinic
Information provided by: The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01302301

Achalasia and esophageal spasm are primary esophageal motility disorders where the lower esophageal sphincter fails to relax in response to swallowing with no well understood underlying cause. Surgical myotomy represents an appropriate therapeutic option. The purpose of this study is to evaluate flexible endoscopic myotomy a novel therapeutic approach to overcome the need for invasive surgery.

Condition Intervention Phase
Esophageal Motility Disorders Procedure: Per oral endolumenal myotomy Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Atypical Primary Motility Disorders Such as Achalasia and Esophageal Spasm

Resource links provided by NLM:

Further study details as provided by The Oregon Clinic:

Primary Outcome Measures:

  • Esophageal Function Tests [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    upper endoscopy, barium swallow, esophageal manometry,ph Test

Secondary Outcome Measures:

  • Quality of life score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    quality of life questionaire

Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:

    Procedure: Per oral endolumenal myotomy

    flexible endoscopic submucosal esophageal partial myotomy

Detailed Description:

In this study, the investigators propose the use of a recent endolumenal technique for partial myotomy in patients suffering from primary esophageal motility disorders.

Under general anesthesia patients will have upper endoscopy. Submucosal injection and mucosal incision is created for entry into the submucosal space. A submucosal tunnel is then created using a needle knife or blunt dissection as appropriate. Dissection will continue distally beyond the lower esophageal sphincter. The inner circular muscle fibers will then be divided to achieve an adequate myotomy length. The mucosal entry is then closed appropriately.

Results will be compared to historical data of conventional Heller myotomies.


Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Candidate for elective Heller myotomy
  • Ability to undergo general anesthesia
  • Ability to give informed consent

Exclusion Criteria:

  • Previous mediastinal or esophageal surgery
  • Contraindications for EGD
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302301

Contact: Lee L Swanstrom, MD 503 281 0561 lswanstrom@aol.com

United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Lee L Swanstrom, MD     503-281-0561     lswanstrom@aol.com    
Sub-Investigator: Christy M Dunst, MD            
Sub-Investigator: Erwin Rieder, MD            
Sub-Investigator: Angi Gill, RN            
Sponsors and Collaborators
The Oregon Clinic
  More Information


Responsible Party: Lee L. Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01302301    
History of Changes
Other Study ID Numbers: PROV10-117A
Study First Received: February 23, 2011
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Oregon Clinic:

endolumenal myotomy, per oral endoscopic myotomy

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Gastrointestinal Diseases
Digestive System Diseases
Deglutition Disorders

ClinicalTrials.gov processed this record on August 21, 2012

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