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Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia

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ClinicalTrials.gov Identifier: NCT01302288
Recruitment Status : Unknown
Verified October 2010 by The Oregon Clinic.
Recruitment status was:  Recruiting
First Posted : February 24, 2011
Last Update Posted : February 28, 2011
Sponsor:
Information provided by:
The Oregon Clinic

Study Description
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Brief Summary:
Achalasia is a primary esophageal motility disorder 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
Achalasia 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 esophageal achalasia.

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 Achalasia
Study Start Date : October 2010
Estimated Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Procedure: Per oral endolumenal myotomy
    patient cohort having flexible endoscopic submucosal esophageal partial myotomy

Outcome Measures
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Primary Outcome Measures :
  1. Esophageal function testing [ Time Frame: 6 months ]
    esophageal manometry test, pH test, upper endoscopy,barium swallow


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


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

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
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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): NCT01302288


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

Locations
United States, Oregon
Good Samaritan Hospital, Legacy Health System Recruiting
Portland, Oregon, United States, 97210
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Lee L. Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01302288     History of Changes
Other Study ID Numbers: LEG1056
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: February 28, 2011
Last Verified: October 2010

Keywords provided by The Oregon Clinic:
endolumenal myotomy, per oral endoscopic myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases