Endolumenal Partial Myotomy for Esophageal Motility Disorders

The Oregon Clinic

Status and phase: Unknown; Phase 2

Conditions: Esophageal Motility Disorders

Treatments: Procedure: Per oral endolumenal myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01302301

PROV10-117A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)