Clinical Trial: Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

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

Official Title: Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia

Brief Summary: This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.

Detailed Summary: By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.
Sponsor: The Oregon Clinic

Current Primary Outcome: Improved quality of life as defined by survey pre and post surgery [ Time Frame: six months ]

patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Negative pH test [ Time Frame: six months ]
    Patients will be required to have 24 hour pH testing after surgery.
  • Bleeding [ Time Frame: 1 year ]
    recorded blood loss will be taken during surgery.


Original Secondary Outcome: Same as current

Information By: The Oregon Clinic

Dates:
Date Received: July 19, 2011
Date Started: September 2010
Date Completion: September 2013
Last Updated: April 12, 2012
Last Verified: April 2012