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Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by The Oregon Clinic.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302288
First Posted: February 24, 2011
Last Update Posted: February 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Oregon Clinic
February 23, 2011
February 24, 2011
February 28, 2011
October 2010
October 2012   (Final data collection date for primary outcome measure)
Esophageal function testing [ Time Frame: 6 months ]
esophageal manometry test, pH test, upper endoscopy,barium swallow
Same as current
Complete list of historical versions of study NCT01302288 on ClinicalTrials.gov Archive Site
Quality of life score [ Time Frame: 6 months ]
quality of life questionaire
Same as current
Not Provided
Not Provided
 
Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia
Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Achalasia
Procedure: Per oral endolumenal myotomy
patient cohort having flexible endoscopic submucosal esophageal partial myotomy
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
Not Provided
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01302288
LEG1056
Yes
Not Provided
Not Provided
Lee L. Swanstrom, MD, The Oregon Clinic
The Oregon Clinic
Not Provided
Not Provided
The Oregon Clinic
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP