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:

Information provided by:

The Oregon Clinic

ClinicalTrials.gov Identifier:

NCT01302288

First received: February 23, 2011

Last updated: February 25, 2011

Last verified: October 2010

History of Changes

Purpose

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.

Condition	Intervention	Phase
Achalasia	Procedure: Per oral endolumenal myotomy	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Endoscopic Submucosal Tunnel Dissection for Endolumenal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Genetic and Rare Diseases Information Center resources: Idiopathic Achalasia Cardiospasm

U.S. FDA Resources

Further study details as provided by The Oregon Clinic:

Primary Outcome Measures:

Esophageal function testing [ Time Frame: 6 months ]
esophageal manometry test, pH test, upper endoscopy,barium swallow

Secondary Outcome Measures:

Quality of life score [ Time Frame: 6 months ]
quality of life questionaire


Estimated Enrollment:	20
Study Start Date:	October 2010
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Intervention Details:

patient cohort having flexible endoscopic submucosal esophageal partial myotomy

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302288

Contacts


Contact: Lee L Swanstrom, MD	503 281 0561	lswanstrom@aol.com

Locations


United States, Oregon
Good Samaritan Hospital, Legacy Health System	Recruiting
Portland, Oregon, United States, 97210
Contact: Lee L Swanstrom, MD 503-281-0561 lswanstrom@aol.com
Sub-Investigator: Christy M Dunst, MD
Sub-Investigator: Erwin Rieder, MD
Sub-Investigator: Angi Gill, RN

Sponsors and Collaborators

The Oregon Clinic

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.


Responsible Party:	Lee L. Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier:	NCT01302288 History of Changes
Other Study ID Numbers:	LEG1056
Study First Received:	February 23, 2011
Last Updated:	February 25, 2011

Keywords provided by The Oregon Clinic:


endolumenal myotomy, per oral endoscopic myotomy

Additional relevant MeSH terms:


Esophageal Achalasia Esophageal Motility Disorders Deglutition Disorders	Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on July 21, 2017

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