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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01302288
Other study ID # LEG1056
Secondary ID
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. completion date
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


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
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