Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2019 |
Start Date: | March 2013 |
End Date: | December 2022 |
Contact: | Peter V Draganov, MD |
Email: | peter.draganov@medicine.ufl.edu |
Phone: | 352-273-9474 |
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.
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.
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.
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.
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.
We found this trial at
2
sites
Gainesville, Florida 32610
Principal Investigator: Peter V Draganov, MD
Phone: 352-273-9400
Click here to add this to my saved trials
Gainesville, Florida 32611
Principal Investigator: Peter V Draganov, MD
Phone: 352-273-9474
Click here to add this to my saved trials