Peroral Endoscopic Myotomy (POEM) for the Treatment of Achalasia

Completed

Conditions studied: Achalasia

In brief

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.

Key facts

Study ID
NCT01832779
Run by
University of Florida
People needed
143
Starts
2013-03-01
Expected to finish
2024-05-01
Last updated by the study team
2024-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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