What side effects are associated with this type of intervention?

Per-Oral Endoscopic Myotomy (POEM) is a common treatment for Achalasia that involves endoscopic cutting of the lower esophageal sphincter muscle to improve food passage. Known side effects of POEM include mild to moderate bleeding, perforations, and a small risk of severe complications. The procedure generally has a high success rate, with most patients experiencing significant improvement in symptoms. However, some patients may experience symptom recurrence over time.

What prior FDA approvals exist?

The FDA has approved several treatments for Achalasia, primarily focusing on methods to reduce the pressure at the lower esophageal sphincter to facilitate food passage. These include pneumatic dilation, which uses a balloon to stretch the sphincter, and botulinum toxin (Botox) injections, which temporarily paralyze the sphincter muscle. Additionally, the Heller myotomy, a surgical procedure that cuts the muscle fibers of the sphincter, has been a standard treatment. While Per-Oral Endoscopic Myotomy (POEM) is a newer, minimally invasive endoscopic technique similar to Heller myotomy, it has shown high success rates and is gaining acceptance as an effective treatment for Achalasia.

What other types of research exist?

Promising, novel alternatives to POEM for Achalasia patients include Endoscopic Submucosal Dissection (ESD) and Gastric Peroral Endoscopic Myotomy (G-POEM). ESD is a technique that allows for en bloc resection of larger tumors and deeper resection margins, which may be beneficial for certain patients. G-POEM, while primarily used for gastroparesis, has shown potential in treating esophageal motility disorders and may offer a less invasive option with lower complication rates.

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Procedure

Per-Oral Endoscopic Myotomy (POEM) for Achalasia (POEM Trial)

N/A

Waitlist Available

Led By Steven Leeds, MD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient with symptomatic achalasia or EGJ outflow obstruction with a motility study, esophagram, and EGD consistent with EGJ outflow obstruction

Medical indication for surgical myotomy

Must not have

Malignant or premalignant esophageal lesion

Barrett's esophagus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a procedure using an endoscope to cut certain muscles in the esophagus. It targets people with achalasia who have trouble swallowing. The treatment aims to reduce swallowing problems without causing much acid reflux. This procedure was first attempted by Inoue for the treatment of achalasia in humans.

Who is the study for?

This trial is for adults aged 18-85 with swallowing disorders, specifically achalasia or EGJ outflow obstruction confirmed by medical tests. Participants must be able to undergo general anesthesia and give informed consent. It's not for those with esophageal cancer risks, strictures, Barrett's esophagus, pregnancy, previous chest radiotherapy or conditions preventing EGD.

What is being tested?

The study is testing the effectiveness of Per-Oral Endoscopic Myotomy (POEM), a less invasive surgical procedure designed to improve swallowing in patients with achalasia—a condition that affects the ability of the esophagus to move food toward the stomach.

What are the potential side effects?

Possible side effects from POEM may include sore throat, pain or discomfort in the chest area due to gas insufflation during surgery, infection risk at incision sites inside the mouth or throat and potential complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a swallowing disorder due to a blockage.

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I need surgery to cut muscles in my digestive tract.

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I can safely be put under general anesthesia.

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I am between 18 and 85 years old and can make my own medical decisions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a cancerous or potentially cancerous lesion in my esophagus.

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I have Barrett's esophagus.

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I have a narrowing in my esophagus.

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I cannot undergo an upper GI endoscopy due to health risks.

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I have been diagnosed with eosinophilic esophagitis.

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I have had radiation therapy to my chest before.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in swallowing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: POEM procedureExperimental Treatment1 Intervention

Patients who underwent POEM

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

POEM

2015

N/A

~140

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Achalasia treatments primarily focus on reducing the pressure at the lower esophageal sphincter (LES) to facilitate food passage. Per-Oral Endoscopic Myotomy (POEM) involves endoscopically cutting the LES muscle, directly addressing the dysfunction and improving swallowing. This is significant for achalasia patients as it alleviates symptoms like dysphagia and chest pain. Other treatments include pneumatic dilation, which stretches the LES with a balloon, and Heller myotomy, a surgical procedure to cut the LES muscle. These interventions are essential for enhancing the quality of life by easing the swallowing process and reducing discomfort.