Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia

Achalasia Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

• NCT number: NCT01302288
• Study type: Interventional
• Source: The Oregon Clinic
• Contact: Lee L Swanstrom, MD
• Phone: 503 281 0561
• Email: lswanstrom@aol.com
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2010