Endolumenal Partial Myotomy for Esophageal Motility Disorders

• Sponsor: The Oregon Clinic (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01302301
• Collaborator: (none)
• Enrollment: 20
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Motility Disorders	Procedure: Per oral endolumenal myotomy	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Atypical Primary Motility Disorders Such as Achalasia and Esophageal Spasm
• Study Start Date: Jan 1, 2011
• Anticipated Primary Completion Date: Nov 1, 2011

Outcome Measures

Primary Outcome Measures

1. Esophageal Function Tests [6 month]

   upper endoscopy, barium swallow, esophageal manometry,ph Test

Secondary Outcome Measures

1. Quality of life score [6 months]

   quality of life questionaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Portland Medical Center	Portland	Oregon	United States	97213

Sponsors and Collaborators

• The Oregon Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.

• ClinicalTrials.gov Identifier: NCT01302301
• Other Study ID Numbers: PROV10-117A
• First Posted: Feb 24, 2011
• Last Update Posted: Feb 28, 2011
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: endolumenal myotomy, per oral endoscopic myotomy
• Additional relevant MeSH terms: Esophageal Motility Disorders; Esophageal Spasm, Diffuse

Study Results

No Results Posted as of Feb 28, 2011