Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia
- Conditions
- Achalasia
- Registration Number
- NCT01302288
- Lead Sponsor
- The Oregon Clinic
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Candidate for elective Heller myotomy
- Ability to undergo general anesthesia
- Ability to give informed consent
- Previous mediastinal or esophageal surgery
- Contraindications for EGD
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Esophageal function testing 6 months esophageal manometry test, pH test, upper endoscopy,barium swallow
- Secondary Outcome Measures
Name Time Method Quality of life score 6 months quality of life questionaire
Trial Locations
- Locations (1)
Good Samaritan Hospital, Legacy Health System
🇺🇸Portland, Oregon, United States