Clinical Trial: Endolumenal Partial Myotomy for Esophageal Motility Disorders

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.

Sponsor: The Oregon Clinic

Current Primary Outcome: Esophageal Function Tests [ Time Frame: 6 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of life score [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: The Oregon Clinic

Dates:
Date Received: February 23, 2011
Date Started: January 2011
Date Completion:
Last Updated: February 25, 2011
Last Verified: November 2010