Endolumenal Partial Myotomy for Esophageal Motility Disorders

Phase 2

• Conditions: Esophageal Motility Disorders

• Registration Number: NCT01302301
• Lead Sponsor: The Oregon Clinic

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 Description

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.

Study Timeline

• Status Verified: 2010-11
• Study Start: 2011-01
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Last Update Submitted: 2011-02-25
• Last Update Posted: 2011-02-28
• Primary Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Candidate for elective Heller myotomy
• Ability to undergo general anesthesia
• Ability to give informed consent

Exclusion Criteria

• Previous mediastinal or esophageal surgery
• Contraindications for EGD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Esophageal Function Tests	6 month	upper endoscopy, barium swallow, esophageal manometry,ph Test

Secondary Outcome Measures

Name	Time	Method
Quality of life score	6 months	quality of life questionaire

Trial Locations

Locations (1)

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States