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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01302288
• Other study ID #: LEG1056
• Status: Recruiting
• Phase: Phase 2
• First received: February 23, 2011
• Last updated: February 25, 2011
• Start date: October 2010

Study information

• Verified date: October 2010
• Source: The Oregon Clinic
• Contact: Lee L Swanstrom, MD
• Phone: 503 281 0561
• Email: lswanstrom[@]aol.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Procedure:
• Per oral endolumenal myotomy
patient cohort having flexible endoscopic submucosal esophageal partial myotomy

Locations

Country	Name	City	State
United States	Good Samaritan Hospital, Legacy Health System	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
The Oregon Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal function testing	esophageal manometry test, pH test, upper endoscopy,barium swallow	6 months	No
Secondary	Quality of life score	quality of life questionaire	6 months	No