Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia (POEM)
This study is currently recruiting participants.
Verified April 2012 by The Oregon Clinic

First Received on July 19, 2011.  
Last Updated on April 12, 2012  
History of Changes
Sponsor: The Oregon Clinic
Information provided by (Responsible Party): Lee Swanstrom, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01399476
  Purpose

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 Intervention Phase
Achalasia Procedure: Endoscopic Myotomy
Procedure: Endoscopic Myotomy for treatment of achalasia
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Submucosal Tunnel Dissection for Endoluminal Partial Myotomy of the Lower Esophageal Sphincter for Achalasia

Resource links provided by NLM:

Further study details as provided by The Oregon Clinic:

Primary Outcome Measures:

  • Improved quality of life as defined by survey pre and post surgery [ Time Frame: six months ] [ Designated as safety issue: No ]
    patients diagnosed with achalasia will be given a quality of life survey before surgery and again six months after surgery.

Secondary Outcome Measures:

  • Negative pH test [ Time Frame: six months ] [ Designated as safety issue: No ]
    Patients will be required to have 24 hour pH testing after surgery.

  • Bleeding [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    recorded blood loss will be taken during surgery.

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations

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

No publications provided

Responsible Party: Lee Swanstrom, Lee Swanstrom, MD, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT01399476    
History of Changes
Other Study ID Numbers: 1056
Study First Received: July 19, 2011
Last Updated: April 12, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The Oregon Clinic:

Achalasia

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on August 21, 2012

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