Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia
Study Details
Study Description
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 |
---|---|---|
|
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
Outcome Measures
Primary Outcome Measures
- Esophageal function testing [6 months]
esophageal manometry test, pH test, upper endoscopy,barium swallow
Secondary Outcome Measures
- Quality of life score [6 months]
quality of life questionaire
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Good Samaritan Hospital, Legacy Health System | Portland | Oregon | United States | 97210 |
Sponsors and Collaborators
- The Oregon Clinic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- LEG1056