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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a procedure called Per-Oral Endoscopic Myotomy (POEM) to determine its effectiveness in treating achalasia, a condition where swallowing is difficult because the esophagus doesn't move food properly. The goal is to assess whether POEM can assist those requiring surgery for this swallowing issue. Suitable candidates for this trial are individuals with significant swallowing difficulties due to achalasia who have been advised to undergo surgery. As an unphased trial, this study provides a unique opportunity to explore a potentially effective treatment for achalasia before it becomes widely available.

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 prior data suggests that the POEM procedure is safe for treating achalasia?

Research has shown that Per-Oral Endoscopic Myotomy (POEM) is generally safe for treating achalasia, a condition that makes swallowing difficult. One study found that POEM improved symptoms for 95.7% of patients three months after the procedure.

Another study reported that 98.9% of the procedures were completed as planned. However, about 4 out of 100 patients required additional treatment because their symptoms did not improve sufficiently.

For long-term results, about 82.2% of patients maintained successful outcomes five years later. While POEM works well for most, some may need further assistance over time.

Overall, these studies indicate that POEM is well-tolerated and has a high success rate, though there is a small chance of needing additional treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Per-Oral Endoscopic Myotomy (POEM) is unique because it offers a less invasive alternative for treating achalasia compared to traditional surgical methods like Heller myotomy. Unlike the standard surgical approach, POEM is performed endoscopically, which means it doesn't require external incisions and can lead to quicker recovery times. Researchers are excited about POEM because it targets the underlying cause of achalasia by cutting the esophageal muscle internally, potentially offering effective symptom relief with fewer complications. This innovative technique could revolutionize the way patients experience treatment and recovery for this challenging condition.

What evidence suggests that the POEM procedure is effective for achalasia?

Research has shown that Per-Oral Endoscopic Myotomy (POEM) is a promising treatment for achalasia, a condition affecting the esophagus. Studies have found that POEM is highly successful, with 94% of patients experiencing positive results after 5-6 years. One study reported an 87% success rate, although about 20% of patients experienced some reflux symptoms afterward. In the short term, nearly 99% of patients had successful outcomes immediately after the procedure, and 95.7% maintained success three months later. These findings suggest that POEM is an effective and reliable option for treating achalasia. ^{3 6 7 8 9}

Who Is on the Research Team?

Steven Leeds, MD

Principal Investigator

Baylor Health Care System

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7165007/

Long-term outcomes of per-oral endoscopic myotomy in ... Available data compare favorably to laparoscopic Heller myotomy (LHM) with clinical success reported to be 76.1 % at 5 years . The primary aim of the current ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36484306/

The outcome of primary per oral endoscopic myotomy ... POEM had a clinical success rate of 94% after 5-6 years since its introduction at the center in 2014, providing a safe and effective treatment for achalasia.

3. aoe.amegroups.org aoe.amegroups.org/article/view/6615/html

Per-oral endoscopic myotomy (POEM) for achalasia Pneumatic dilation improves symptoms in 90% of patients at 6 months and 44% at 6 years, but dilation may be more effective in some patients than in others.

4. endoscopy-campus.com endoscopy-campus.com/en/ec-news/peroral-endoscopic-myotomy-for-achalasia-is-effective-up-to-4-years/

Peroral Endoscopic Myotomy for Achalasia Is Effective up ... Success rates of 87% can be expected in the treated patients, with approximately 20% of the treated patients experiencing post-POEM GERD symptoms. Note to ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0929664621004885

Clinical efficacy and safety of peroral endoscopic myotomy ... In total, 91 patients (98.9%) showed immediate technical success, and the overall clinical success rate at three months after POEM was 95.7%. Nearly 60% of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35442413/

Use and Safety of Per-Oral Endoscopic Myotomy for Achalasia ... Results of this cohort study suggest that POEM was associated with higher health care utilization compared with LHM and lower subsequent ...

7. gut.bmj.com gut.bmj.com/content/74/Suppl_1/A152

P109 Safety and outcomes of per oral endoscopic ... Clinical success rate was 89.5% at 6 months, and 86.2% at 1 year. 4 patients required further intervention for Achalasia due to non improvement in symptoms ...

8. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2791325

Use and Safety of Per-Oral Endoscopic Myotomy for ... This cohort study investigates the use, safety, and costs associated with the use of per-oral endoscopic myotomy for achalasia in the US.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36260203/

Mid-Term and Long-Term Outcomes of Peroral Endoscopic ... Conclusions: POEM is associated with a long-term clinical success of 82.2% after 5 years of follow-up. Randomized control trials comparing POEM with ...