U-POEM vs CO2-POEM for Esophageal Motility Disorder
(U-POEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two methods for performing a procedure called POEM, used to treat esophageal motility disorders (problems with how the esophagus moves food). One method, CO2-POEM, uses carbon dioxide gas, while the other, U-POEM, uses water immersion. The trial aims to determine which method results in less pain after the procedure and requires fewer pain medications. It will also evaluate other factors, such as the procedure's success and the need for hospital admission afterward. Suitable candidates for this trial are those scheduled for a POEM procedure due to esophageal dysmotility (difficulty swallowing or moving food down the esophagus). As an unphased trial, this study offers patients the chance to contribute to medical knowledge and potentially benefit from innovative treatment methods.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In earlier studies, U-POEM has shown great success with few side effects. One study demonstrated that U-POEM was effective for 95.7% of patients after three months, with minimal complications. Another study confirmed its effectiveness and safety, yielding good results for patients.
For CO2-POEM, research also indicates it is safe and effective. Patients can safely return home the same day after the procedure, and studies have reported a success rate between 90.8% and 100% in older patients. Some studies mention possible minor issues like air leaks, which are usually easy to manage.
Both techniques are generally well-tolerated, with only a few minor risks.12345Why are researchers excited about this trial?
Researchers are excited about the U-POEM and CO2-POEM techniques for treating esophageal motility disorders because they offer unique approaches to improving patient outcomes. Unlike traditional methods that typically use carbon dioxide insufflation, U-POEM employs water immersion to distend the gastrointestinal tract, potentially reducing the risk of gas-related complications and improving visualization during the procedure. CO2-POEM, on the other hand, utilizes carbon dioxide, which is absorbed more rapidly than air, minimizing patient discomfort and reducing recovery time. These innovative techniques could lead to safer and more effective treatment options for patients with esophageal motility disorders.
What evidence suggests that this trial's treatments could be effective for esophageal motility disorder?
This trial compares two methods of Peroral Endoscopic Myotomy (POEM) for treating swallowing disorders: CO2-POEM and U-POEM. Research has shown that POEM effectively relieves symptoms in the short term for 90% to 100% of patients and over 80% in the long term. In this trial, the CO2-POEM method uses carbon dioxide for insufflation, which reduces gas-related issues due to the rapid absorption of the gas. Meanwhile, U-POEM, another method under study, uses water instead of gas, achieving high success rates and avoiding gas-related problems. Both methods are safe and effective, but U-POEM may offer additional benefits, such as improved patient comfort.678910
Who Is on the Research Team?
Dennis Yang, MD
Principal Investigator
AdventHealth Medical Group
Are You a Good Fit for This Trial?
This trial is for individuals with Nutcracker Esophagus, Esophageal Spasm, or other Esophageal Motility Disorders. Participants will be chosen based on specific inclusion and exclusion criteria that are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Per-Oral Endoscopic Myotomy (POEM) using either CO2 or water immersion for luminal distension
Post-procedural Monitoring
Participants are monitored for post-procedural pain and other outcomes using Numeric Pain Scale and Pain Quality Assessment Scale
Follow-up
Participants are monitored for safety, effectiveness, and readmission rates up to 6 months post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- CO2-POEM
- U-POEM
Find a Clinic Near You
Who Is Running the Clinical Trial?
AdventHealth
Lead Sponsor
Mayo Clinic
Collaborator
University of Florida
Collaborator
California Pacific Medical Center
Collaborator