Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01832779
First received: April 2, 2013
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

Achalasia is a chronic disease of altered esophageal motility with resulting functional obstruction to the passage of food leading to poor quality of life and significant morbidity. The two main treatments available in the US are endoscopic balloon dilation and surgical myotomy. Each therapy has advantages and drawbacks and at present both are considered a first choice approach depending on patient preferences and local expertise. Surgical myotomy provides long lasting improvement in dysphagia but even when done laparoscopically is invasive and complex. Extensive acid reflux resulting in significant morbidity is routinely seen after surgical myotomy and additional anti-reflux operation is typically done at the time of the myotomy. Endoscopic balloon dilation is a simple minimally invasive outpatient procedure but improvement of symptoms tends to be shorter in duration and repeat dilations are commonly needed. Both therapies improve on dysphagia but tend to provide suboptimal control of chest pain which is one of the cardinal symptoms of achalasia.

The peroral endoscopic myotomy (POEM) was first introduced in Japan to address the suboptimal results with endoscopic balloon dilation and surgical myotomy. POEM is incisionless minimally invasive but in addition may have some further advantages over surgical myotomy including unlimited length of the myotomy with expected better control of chest pain and preservation of the anatomical anti-reflux barrier (angle of His and the cruse of the diaphragm) with expected lower incidence of acid reflux.

In Japan POEM has become the preferred modality for therapy of achalasia due to the excellent results and exceptional safety record. In the US, dedicated POEM devices were approved by the FDA just recently. As a result the bulk of the published data comes from Japan and very little is known regarding outcomes in US population. Therefore the investigators want to prospectively record our experience with POEM as done as part of routine medical care in US population. This will be a data recording study. All patients will receive standard medical care and no experimental interventions will be performed.


Condition Intervention
Achalasia
Other: Achalasia subjects

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy (POEM)

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Response to POEM treatment [ Time Frame: approximately one week ] [ Designated as safety issue: No ]

    Information about the subject's medical history, leading up to the need for an Achalasia treatment, the procedure itself and how the subject does after the procedure, including after the subject gets home, will be collected.

    This information will be collected by gathering relevant information from the subject's medical chart and/or by talking with the subject prior to and after the subject's medical procedures.

    There are no specific study procedures or tests. All information collected is part of the subject's medical care and will be collected even if the subject is not in the study.



Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Achalasia subjects
Information about teh subject's medical history, leading up to the need for an Achalasia treatment, the procedure itself and how the subject does after the procedure, including after the subject gets home, will be collected. This will be done by gathering relevant information from the subject's medical chart and/or by talking with the subject prior to and after the subject's medical procedures. There are no specific study procedures or tests. All information collected is part of the subject's medical care and will be collected even if the subject is not in the study.
Other: Achalasia subjects
Information about the subject's medical history, leading up to the need for an Achalasia treatment, the procedure itself and how the subject does after the procedure, including after the subject's gets home, will be collected. This will be done by gathering relevant information from the subject's medical chart and/or by talking with the subject prior to and after your medical procedures. There are no specific study procedures or tests. All information collected is part of the subject's medical care and will be collected even if the subject is not in the study.
Other Name: Peroral Endoscopic Myotomy

Detailed Description:

Information about the subject's medical history, leading up to the need for an Achalasia treatment, the procedure itself and how the subject does after the procedure, including after the subject gets home, will be collected. This will be done by gathering relevant information from the subject's medical chart and/or by talking with the subject prior to and after the subject's medical procedures. There are no specific study procedures or tests. All information collected is part of the subject's medical care and will be collected even if the subject is not in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Those subjects with Achalasia who have been referred for the POEM treatment for their Achalasia.

Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Scheduled to undergo POEM treatment

Exclusion Criteria:

  • Any contraindication to performing endoscopy
  • Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
  • The subject is unable/unwilling to give informed consent.
  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: NCT01832779

Contacts
Contact: Peter V Draganov, MD 352-273-9474 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
Shands UF Health Recruiting
Gainesville, Florida, United States, 32610
Contact: Peter V Draganoc, MD    352-273-9400    peter.draganov@medicine.ufl.edu   
Principal Investigator: Peter V Draganov, MD         
University of Florida Shands Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Peter V Draganov, MD    352-273-9474    peter.draganov@medicine.ufl.edu   
Principal Investigator: Peter V Draganov, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter V Draganov, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01832779     History of Changes
Other Study ID Numbers: 201300104
Study First Received: April 2, 2013
Last Updated: October 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Achalasia

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

ClinicalTrials.gov processed this record on October 29, 2014