U-POEM vs CO2-POEM for Esophageal Motility Disorder

(U-POEM Trial)

Overseen By Petronio T Senior Clinical Research Operations Manager, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Esophageal stricture, Malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

36 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment CO2-POEM and U-POEM for esophageal motility disorder?

Research shows that peroral endoscopic myotomy (POEM) is effective for treating esophageal motility disorders, including achalasia, with good safety and long-term outcomes. POEM has been performed in over 10,000 patients worldwide, demonstrating its efficacy and minimal invasiveness compared to traditional treatments. ^{1 2 3 4 5}

Is POEM a safe treatment for esophageal motility disorders?

POEM (Peroral Endoscopic Myotomy) is generally considered safe for treating esophageal motility disorders, with studies showing successful outcomes and manageable side effects like gastroesophageal reflux and minor complications. It has been performed safely in both younger and older patients, with careful management of anesthesia and post-procedure care. ^{1 6 7 8 9}

How does the U-POEM vs CO2-POEM treatment differ from other treatments for esophageal motility disorder?

U-POEM and CO2-POEM are unique treatments for esophageal motility disorders because they involve a minimally invasive procedure called peroral endoscopic myotomy (POEM), which directly targets the muscle layers of the esophagus to improve swallowing. This approach is different from traditional treatments like pneumatic dilation, as it offers a more precise and potentially longer-lasting solution with a focus on reducing muscle tightness in the esophagus. ^{6 10 11 12 13}

What is the purpose of this trial?

Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater). POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications. Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials Aim 1. The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM. Aim 2. Compare the proportion of patients that require post-procedural admission for pain management. Aim 3. Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM. Aim 4. Compare technical and clinical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure whereas clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up. Aim 5. Compare and evaluate procedural characteristics between the two groups. 1. Compare procedural time between U-POEM and CO2-POEM. 2. Compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels. 3. Adverse event rate (i.e. bleeding, perforation).

Research Team

Dennis Yang, MD

Principal Investigator

AdventHealth Medical Group

Eligibility Criteria

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

Ability to provide informed consent

I am scheduled for a POEM procedure for esophagus issues.

Exclusion Criteria

I have no health conditions that prevent me from safely undergoing anesthesia or a colonoscopy.

I am unable to understand or sign the consent form.

I have no conditions that would prevent me from having a POEM procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Per-Oral Endoscopic Myotomy (POEM) using either CO2 or water immersion for luminal distension

1 day

1 visit (in-person)

Post-procedural Monitoring

Participants are monitored for post-procedural pain and other outcomes using Numeric Pain Scale and Pain Quality Assessment Scale

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and readmission rates up to 6 months post-procedure

6 months

1 visit (in-person), additional follow-up as needed

Treatment Details

Interventions

• CO2-POEM
• U-POEM

Trial Overview The study compares two methods of Per-Oral endoscopic myotomy (POEM) for esophageal conditions: CO2-POEM using carbon dioxide gas and U-POEM using underwater immersion. It aims to assess post-procedural pain, hospital admissions for pain management, analgesic needs, procedure success rates, and procedural characteristics.

Participant Groups

Group I: U-POEM Experimental Treatment 1 Intervention

Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation

Group II: CO2-POEM Experimental Treatment 1 Intervention

POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air.

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

California Pacific Medical Center

Collaborator

Trials

13

Recruited

8,200+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Rethinking the need for overnight admission after peroral endoscopic myotomy (POEM): a pandemic-driven approach to the future. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of the Outcomes of Peroral Endoscopic Myotomy for Achalasia According to Manometric Subtype. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Peroral esophageal myotomy for esophageal motility disorders. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

The argument for peroral endoscopic myotomy in treatment of achalasia. [2018]

5. Egypt pubmed.ncbi.nlm.nih.gov

A New Preparation Method for Peroral Endoscopic Myotomy in Patients with Achalasia Can Effectively Reduce the Esophageal Residual Contents: A Comparative Retrospective Study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Peroral endoscopic myotomy (POEM) vs pneumatic dilation (PD) in treatment of achalasia: A meta-analysis of studies with ≥ 12-month follow-up. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Peroral Endoscopic Myotomy for Esophageal Achalasia and Achalasia-Related Diseases in Patients Aged 75 Years and Over. [2021]

8. Japan pubmed.ncbi.nlm.nih.gov

Anesthetic management of peroral endoscopic myotomy for esophageal achalasia: a retrospective case series. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Per-oral endoscopic myotomy for achalasia cardia: outcomes in over 400 consecutive patients. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[Effects of peroral endoscopic myotomy on esophageal dynamics in patients with esophageal achalasia]. [2012]

11. England pubmed.ncbi.nlm.nih.gov

DUAL-POEM for associated esophageal and gastric motility disorders: case series of endoscopic cardiomyotomy and endoscopic pyloromyotomy. [2021]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Myotomy of Distal Esophagus Influences Proximal Esophageal Contraction and Upper Esophageal Sphincter Relaxation in Patients with Achalasia After Peroral Endoscopic Myotomy. [2020]

13. Australia pubmed.ncbi.nlm.nih.gov

Effect of peroral endoscopic myotomy in achalasia patients with failure of prior pneumatic dilation: a prospective case-control study. [2014]