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Endolumenal Partial Myotomy for Esophageal Motility Disorders

Primary Purpose

Esophageal Motility Disorders

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Per oral endolumenal myotomy
Sponsored by
The Oregon Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Motility Disorders focused on measuring endolumenal myotomy, per oral endoscopic myotomy

Eligibility Criteria

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

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

Sites / Locations

  • Providence Portland Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Esophageal Function Tests
upper endoscopy, barium swallow, esophageal manometry,ph Test

Secondary Outcome Measures

Quality of life score
quality of life questionaire

Full Information

First Posted
February 23, 2011
Last Updated
February 25, 2011
Sponsor
The Oregon Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01302301
Brief Title
Endolumenal Partial Myotomy for Esophageal Motility Disorders
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Oregon Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Motility Disorders
Keywords
endolumenal myotomy, per oral endoscopic myotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Per oral endolumenal myotomy
Intervention Description
flexible endoscopic submucosal esophageal partial myotomy
Primary Outcome Measure Information:
Title
Esophageal Function Tests
Description
upper endoscopy, barium swallow, esophageal manometry,ph Test
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Quality of life score
Description
quality of life questionaire
Time Frame
6 months

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lee L Swanstrom, MD
Phone
503 281 0561
Email
lswanstrom@aol.com
Facility Information:
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee L Swanstrom, MD
Phone
503-281-0561
Email
lswanstrom@aol.com
First Name & Middle Initial & Last Name & Degree
Christy M Dunst, MD
First Name & Middle Initial & Last Name & Degree
Erwin Rieder, MD
First Name & Middle Initial & Last Name & Degree
Angi Gill, RN

12. IPD Sharing Statement

Citations:
PubMed Identifier
20354937
Citation
Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
Results Reference
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Endolumenal Partial Myotomy for Esophageal Motility Disorders

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