Endolumenal Partial Myotomy for Esophageal Motility Disorders
Recruitment status was: Recruiting
|Esophageal Motility Disorders||Procedure: Per oral endolumenal myotomy||Phase 2|
|Study Design:||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 Atypical Primary Motility Disorders Such as Achalasia and Esophageal Spasm|
- Esophageal Function Tests [ Time Frame: 6 month ]upper endoscopy, barium swallow, esophageal manometry,ph Test
- Quality of life score [ Time Frame: 6 months ]quality of life questionaire
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||November 2011 (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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302301
|Contact: Lee L Swanstrom, MD||503 281 firstname.lastname@example.org|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Lee L Swanstrom, MD 503-281-0561 email@example.com|
|Sub-Investigator: Christy M Dunst, MD|
|Sub-Investigator: Erwin Rieder, MD|
|Sub-Investigator: Angi Gill, RN|