Per-Oral Endoscopic Myotomy (POEM) for Achalasia

(POEM Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Previous chest radiotherapy, Eosinophilic esophagitis, Barrett's esophagus, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 Per-Oral Endoscopic Myotomy (POEM) for achalasia?

Research shows that POEM is a popular and effective treatment for achalasia, a condition where the esophagus (the tube that carries food from the mouth to the stomach) has trouble moving food down. It is also considered promising for other esophageal disorders, and studies suggest it can be safely adopted into clinical practice. ^{1 2 3 4 5}

Is Per-Oral Endoscopic Myotomy (POEM) generally safe for humans?

Per-Oral Endoscopic Myotomy (POEM) is considered a safe treatment for esophageal achalasia, but it can have some adverse effects like reflux symptoms. Studies have shown that while it is effective, there can be adverse events that may lead to longer hospital stays. ^{4 6 7 8 9}

How is the treatment POEM different from other treatments for achalasia?

POEM is unique because it is a minimally invasive endoscopic procedure that allows doctors to cut the muscles at the lower end of the esophagus without making large incisions, which can lead to quicker recovery and less pain compared to traditional surgery. ^{3 4 5 10 11}

Research Team

Steven Leeds, MD

Principal Investigator

Baylor Health Care System

Eligibility Criteria

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.

Inclusion Criteria

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

I need surgery to cut muscles in my digestive tract.

I can safely be put under general anesthesia.

Exclusion Criteria

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

I have Barrett's esophagus.

I have a narrowing in my esophagus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Per-Oral Endoscopic Myotomy (POEM) procedure for the treatment of esophageal swallowing disorders

1 day

1 visit (in-person)

Follow-up

Participants are monitored for improvement in swallowing and potential development of GERD

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Per-Oral Endoscopic Myotomy (POEM)

Trial Overview 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.

Participant Groups

Group I: POEM procedure Experimental Treatment 1 Intervention

Patients who underwent POEM

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Findings from Research

In a study of 31 patients undergoing per oral endoscopic myotomy (POEM) for achalasia, the procedure showed significant improvement in symptoms, with average preoperative Eckardt scores of 6.3 dropping to 2.2 after one year, indicating effective treatment.

The multidisciplinary approach to POEM resulted in a low average hospital stay of 1.3 days and a low complication rate, demonstrating both safety and efficiency in adopting this technique for achalasia management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Per oral endoscopic myotomy: early experience and safety of a multispecialty approach. Arshava, EV., Marchigiani, RJ., Gerke, H., et al.[2019]

Using optical coherence tomography (OCT) before per-oral endoscopic myotomy (POEM) in 51 patients significantly reduced procedural bleeding compared to a control group, with only 8% experiencing bleeding versus 43% in the control group.

The use of OCT also led to a shorter procedural time, averaging 85.8 minutes compared to 121.7 minutes in the control group, indicating that OCT can enhance the safety and efficiency of the POEM procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography (OCT) prior to peroral endoscopic myotomy (POEM) reduces procedural time and bleeding: a multicenter international collaborative study. Desai, AP., Tyberg, A., Kedia, P., et al.[2018]

The study demonstrated that the combined procedure of per-oral endoscopic myotomy with fundoplication (POEM+F) was successfully performed on three patients with achalasia, indicating its technical feasibility.

No major adverse events were reported during or after the procedure, and the maintenance of the surgical wrap was confirmed at one-month follow-up, suggesting a promising approach to reduce reflux symptoms associated with traditional POEM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Per oral endoscopic myotomy with fundoplication is a technically feasible NOTES for achalasia cardia. Mandavdhare, HS., Samanta, J., Varma, P., et al.[2022]

In a study of 1,826 patients undergoing peroral endoscopic myotomy (POEM), the overall prevalence of adverse events (AEs) was found to be 7.5%, with severe AEs occurring in only 0.5% of cases, indicating that POEM is relatively safe when performed by experienced endoscopists.

Factors such as having a sigmoid-type esophagus, the endoscopist's experience (less than 20 cases), and the type of knife and electrosurgical current used were identified as significant predictors of AEs, highlighting the importance of technique and expertise in minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Analysis of Adverse Events Associated With Per Oral Endoscopic Myotomy in 1826 Patients: An International Multicenter Study. Haito-Chavez, Y., Inoue, H., Beard, KW., et al.[2022]

In a study of 300 patients who underwent peroral endoscopic myotomy (POEM) for achalasia, routine postoperative chest CT scans revealed a high frequency of minor findings, such as pneumomediastinum (48%) and pneumoperitoneum (37%), which were often clinically irrelevant.

Only a small percentage of patients required intervention for complications, with 5.6% needing treatment for pneumothorax and 0.7% for pleural effusion, suggesting that routine CT scans may not be necessary after POEM, especially when using CO2 instead of air to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic CT after peroral endoscopic myotomy for the treatment of achalasia. Cai, MY., Zhou, PH., Yao, LQ., et al.[2016]

References

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

Function of high-resolution manometry in the analysis of peroral endoscopic myotomy for achalasia. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Symptom duration is not associated with per oral endoscopic myotomy (POEM) failure. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Per oral endoscopic myotomy: early experience and safety of a multispecialty approach. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Optical coherence tomography (OCT) prior to peroral endoscopic myotomy (POEM) reduces procedural time and bleeding: a multicenter international collaborative study. [2018]

5. Spain pubmed.ncbi.nlm.nih.gov

Outcomes of peroral endoscopic myotomy in patients with spastic esophageal motility disorders that do not fulfill Chicago Classification criteria. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes of per-oral endoscopic myotomy for treatment of esophageal achalasia with a median follow-up of 49 months. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Per oral endoscopic myotomy with fundoplication is a technically feasible NOTES for achalasia cardia. [2022]

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

Adverse Events Associated With Peroral Endoscopic Myotomy Affecting Extended Hospital Stay: A Multi-center Retrospective Study in South Korea. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Analysis of Adverse Events Associated With Per Oral Endoscopic Myotomy in 1826 Patients: An International Multicenter Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Thoracic CT after peroral endoscopic myotomy for the treatment of achalasia. [2016]

11. Germany pubmed.ncbi.nlm.nih.gov

Safety and efficacy of POEM for treatment of achalasia: a systematic review of the literature. [2022]