Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia (POEM)

October 2, 2024 updated by: University of Florida

Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy (POEM)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Peroral Endoscopic Myotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to POEM treatment
Time Frame: approximately one week

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.
approximately one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Peter V Draganov, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimated)

April 16, 2013

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201300104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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