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POEM: Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia

Sponsor
The Oregon Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01399476
Collaborator
(none)
350
Enrollment
1
Location
1
Arm
107
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Endoscopic Myotomy
  • Procedure: Endoscopic Myotomy for treatment of achalasia
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
350 participants
Allocation:
N/A
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 :
Sep 1, 2010
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Endoscopic Myotomy

Procedure: Endoscopic Myotomy
Patients will receive the surgical procedure described in the summary (POEM).
Other Names:
  • POEM

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improved quality of life as defined by survey pre and post surgery [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 [six months]

      Patients will be required to have 24 hour pH testing after surgery.

    2. Bleeding [1 year]

      recorded blood loss will be taken during surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 The Oregon Clinic Portland Oregon United States 97210

    Sponsors and Collaborators

    • The Oregon Clinic

    Investigators

    • Principal Investigator: Lee L Swanstrom, MD, The Oregon Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lee Swanstrom, Lee Swanstrom, MD, The Oregon Clinic
    ClinicalTrials.gov Identifier:
    NCT01399476
    Other Study ID Numbers:
    • 1056
    First Posted:
    Jul 21, 2011
    Last Update Posted:
    Aug 30, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Lee Swanstrom, Lee Swanstrom, MD, The Oregon Clinic
    Achalasia
    Additional relevant MeSH terms:
    Esophageal Achalasia

    Study Results

    No Results Posted as of Aug 30, 2019