NCT01302288

Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Oregon Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Achalasia

Interventions

Type	Name	Description
PROCEDURE	Per oral endolumenal myotomy	patient cohort having flexible endoscopic submucosal esophageal partial myotomy

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-10-01
• First posted: 2011-02-24
• Last updated: 2011-02-28

Locations

1 site across 1 country: United States