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Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia (POEM)

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ClinicalTrials.gov Identifier: NCT01399476
Recruitment Status : Recruiting
First Posted : July 21, 2011
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Lee Swanstrom, The Oregon Clinic

Brief Summary:
This is a study of the safety and efficacy of a new surgical procedure using endoscopic instruments and a tunneling technique to reach the LES for dissection. We hypothesize that this technique provides an incisionless, less invasive option with similar functional outcome compared to standard Heller myotomy.

Condition or disease Intervention/treatment Phase
Achalasia Procedure: Endoscopic Myotomy Procedure: Endoscopic Myotomy for treatment of achalasia Not Applicable

Detailed Description:
By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer can be easily visualized. In contrast to conventional Heller myotomy, the dissection of only the inner circular esophageal muscle layer leaves the outer longitudinal muscle layer intact. Thereby, post-interventional reflux disease should be avoided.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia
Study Start Date : September 2010
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Endoscopic Myotomy Procedure: Endoscopic Myotomy
Patients will receive the surgical procedure described in the summary (POEM).
Other Name: POEM

Procedure: Endoscopic Myotomy for treatment of achalasia
Surgical procedure
Other Name: POEM




Primary Outcome Measures :
  1. Improved quality of life as defined by survey pre and post surgery [ Time Frame: six months ]
    patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.


Secondary Outcome Measures :
  1. Negative pH test [ Time Frame: six months ]
    Patients will be required to have 24 hour pH testing after surgery.

  2. Bleeding [ Time Frame: 1 year ]
    recorded blood loss will be taken during surgery.



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

Inclusion Criteria:

  • Ability to undergo general anesthesia
  • Age > 18 yrs. of age and < 85 yrs. of age
  • Ability to give informed consent
  • Candidate for elective Heller myotomy

Exclusion Criteria:

  • Previous mediastinal or esophageal surgery
  • Contraindications for esophagogastroduodenoscopy
  • BMI > 45

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399476


Contacts
Contact: Angi B Gill, RN 503-281-0561 agill@orclinic.com

Locations
United States, Oregon
The Oregon Clinic Recruiting
Portland, Oregon, United States, 97210
Contact: Angi B Gill, RN    503-281-0561    agill@orclinic.com   
Principal Investigator: Lee L Swanstrom, MD         
Sponsors and Collaborators
The Oregon Clinic
Investigators
Principal Investigator: Lee L Swanstrom, MD The Oregon Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lee Swanstrom, Lee Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01399476     History of Changes
Other Study ID Numbers: 1056
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017

Keywords provided by Lee Swanstrom, The Oregon Clinic:
Achalasia

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases