NCT01399476

Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: The Oregon Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Achalasia

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Myotomy	Patients will receive the surgical procedure described in the summary (POEM).
PROCEDURE	Endoscopic Myotomy for treatment of achalasia	Surgical procedure

Timeline

• Start date: 2010-09-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2011-07-21
• Last updated: 2019-08-30

Locations

1 site across 1 country: United States