Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia|
- Esophageal function testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]esophageal manometry test, pH test, upper endoscopy,barium swallow
- Quality of life score [ Time Frame: 6 months ] [ Designated as safety issue: No ]quality of life questionaire
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Procedure: Per oral endolumenal myotomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302288
|Contact: Lee L Swanstrom, MD||503 281 email@example.com|
|United States, Oregon|
|Good Samaritan Hospital, Legacy Health System||Recruiting|
|Portland, Oregon, United States, 97210|
|Contact: Lee L Swanstrom, MD 503-281-0561 firstname.lastname@example.org|
|Sub-Investigator: Christy M Dunst, MD|
|Sub-Investigator: Erwin Rieder, MD|
|Sub-Investigator: Angi Gill, RN|