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Endolumenal Partial Myotomy for Esophageal Motility Disorders

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. Identifier: NCT01302301
Recruitment Status : Unknown
Verified November 2010 by The Oregon Clinic.
Recruitment status was:  Recruiting
First Posted : February 24, 2011
Last Update Posted : February 28, 2011
Information provided by:
The Oregon Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Esophageal Motility Disorders Procedure: Per oral endolumenal myotomy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2011
Estimated Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Intervention Details:
  • Procedure: Per oral endolumenal myotomy
    flexible endoscopic submucosal esophageal partial myotomy

Primary Outcome Measures :
  1. Esophageal Function Tests [ Time Frame: 6 month ]
    upper endoscopy, barium swallow, esophageal manometry,ph Test

Secondary Outcome Measures :
  1. Quality of life score [ Time Frame: 6 months ]
    quality of life questionaire

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.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01302301

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Contact: Lee L Swanstrom, MD 503 281 0561

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United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Lee L Swanstrom, MD    503-281-0561   
Sub-Investigator: Christy M Dunst, MD         
Sub-Investigator: Erwin Rieder, MD         
Sub-Investigator: Angi Gill, RN         
Sponsors and Collaborators
The Oregon Clinic
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Responsible Party: Lee L. Swanstrom, MD, The Oregon Clinic Identifier: NCT01302301    
Other Study ID Numbers: PROV10-117A
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 28, 2011
Last Verified: November 2010
Keywords provided by The Oregon Clinic:
endolumenal myotomy, per oral endoscopic myotomy
Additional relevant MeSH terms:
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Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases