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The Role That Peroral Endoscopic Myotomy (POEM) Could Play in the Treatment of Achalasia

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01584635
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
48
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Based on the work of the Doctors at the Mayo Clinic Rochester, a new technique for a less invasive treatment for Achalasia has been developed.

The purpose of this study is to decide the role this less invasive treatment (Peroral Endoscopic Myotomy) has in the treatment of patient's with achalasia.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Peroral Endoscopic Myotomy (POEM) for Treatment of Achalasia
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peroral Endoscopic Myotomy (POEM)

Peroral Endoscopic Myotomy- a less invasive treatment for patients with Achalasia

Procedure: Peroral Endoscopic Myotomy a less invasive treatment for Achalasia
In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit
Other Names:
  • Achalasia
  • Heller myotomy
  • Dysphagia
  • Peroral Endoscopic Myotomy
  • Disease of the muscle of the esophagus.
  • Disorder of the swallowing tube.
  • Esophageal Motility Disorders
  • Esophageal Achalasia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events [5 years post surgery]

      Patients in this study, undergoing the Peroral Endoscopic Myotomy treatment for Achalasia, will be accessed at 1 month, 6 months, at 1-2-3-4 and year 5 post surgery. We will measure outcomes by number of adverse events, Eckardt symptom score, barium esophagram, and manometry studies.

    Secondary Outcome Measures

    1. Eckardt symptom score [5 years]

      By following participants regularly and closely both by symptomatic and objective criteria, we will be able to determine factors that predict response to the POEMS procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients between the ages of 18 and 80 with achalasia diagnosed by a combination of compatible symptoms, barium esophagography and high resolution manometry.
    Exclusion Criteria:

    • Patients who are poor surgical risks, have had previous treatment for achalasia or esophageal or gastric surgery, have an epiphrenic diverticulum or are unwilling to be followed in the protocol.

    • Female patients are eligible if they are NOT pregnant or lactating AND ne of the following criteria is met:

    • The patient is surgically sterile (by means of hysterectomy/bilateral tubal ligation)

    • The patient is at least one year postmenopausal (no menses for 12 months).

    • The patient is using a highly effective method of contraception, if childbearing potential, AND has a negative urine human chorionic gonadotropin beta subunit (ß HCG) pregnancy test result during Screening, and prior to trial drug administration.

    • Highly effective methods of birth control are defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.

    • Withdrawal, single- or double barrier methods (including condoms) and rhythm methods are NOT ACCEPTABLE methods of contraception for the purposes of this clinical trial due to the high incidence of contraceptive failures with these methods.

    • Vulnerable populations, such as those with diminished mental acuity, will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: David Katzka, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David A. Katzka, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01584635
    Other Study ID Numbers:
    • 11-005252
    First Posted:
    Apr 25, 2012
    Last Update Posted:
    Oct 31, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by David A. Katzka, Principal Investigator, Mayo Clinic
    Less invasive treatment for Achalasia
    Additional relevant MeSH terms:
    Esophageal Achalasia

    Study Results

    No Results Posted as of Oct 31, 2016