POEM-F for Achalasia

Recruiting at 6 trial locations

Overseen By Hon Chi Yip, FRCSEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chinese University of Hong Kong

Disqualifiers: Previous esophageal surgery, Obesity, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for achalasia, a condition that makes swallowing difficult due to esophageal issues. It compares the standard procedure, POEM (Peroral Endoscopic Myotomy), with a new method, POEM-F (Per-oral Endoscopic Myotomy with Fundoplication), which includes an additional step to reduce heartburn after treatment. The goal is to determine if POEM-F can lower the risk of post-treatment heartburn (GERD) compared to the standard method. Adults with type I or II achalasia who haven't undergone major esophageal surgery may qualify for this trial. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance future treatment options.

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 this technique is safe for achalasia patients?

Studies have shown that the standard POEM procedure is safe and effective for treating achalasia, a condition that makes swallowing difficult. Research indicates that this procedure has a low rate of side effects and is well-tolerated by most patients. Reports show good long-term results, with many patients experiencing relief from symptoms.

For POEM-F, which includes an extra step to help prevent acid reflux (GERD) after the procedure, early findings suggest it is also safe and practical. A meta-analysis found that POEM-F is a good option for patients with achalasia. It seems to address the main downside of the standard POEM, which is the risk of acid reflux, without adding significant safety concerns.

Both treatments have demonstrated promising safety records in studies. Prospective trial participants should know that experts are carefully evaluating these treatments to ensure maximum safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new technique, POEM-F, for achalasia because it adds a fundoplication step to the conventional per-oral endoscopic myotomy (POEM). This extra step potentially reduces post-procedure gastroesophageal reflux, a common complication with traditional POEM. By combining myotomy with fundoplication, the procedure aims to improve patient outcomes by enhancing the durability of the treatment and minimizing reflux-related side effects. This innovative approach could offer a more comprehensive solution for achalasia patients who currently rely on treatments like medication, pneumatic dilation, or surgery.

What evidence suggests that POEM-F could be an effective treatment for achalasia?

This trial will compare two treatments for achalasia: Conventional POEM and POEM-F. Research has shown that both POEM and POEM-F effectively treat achalasia, a condition affecting the esophagus. Participants may receive Conventional POEM, which improves esophageal function with a high success rate of about 86-89% after one year. However, it can cause acid reflux, or GERD, in up to 50-60% of patients. Alternatively, participants may receive POEM-F, which early studies suggest can relieve achalasia symptoms while reducing the chance of GERD to about 12% after one year. Both treatments are safe and effective, but POEM-F appears to lower the risk of GERD compared to traditional POEM. ^{3 6 7 8 9}

Who Is on the Research Team?

Hon Chi Yip, FRCSEd

Principal Investigator

Chinese University of Hong Kong

Are You a Good Fit for This Trial?

Adults aged 18-65 with symptomatic achalasia types I or II, who are either treatment-naive or have had unsuccessful balloon dilation. Excluded are those with prior esophageal surgery, significant comorbidities preventing anesthesia, obesity (BMI ≥ 30), pregnancy, breastfeeding, large hiatal hernias, or certain blood conditions.

Inclusion Criteria

Capability of understanding and complying with the study requirements, including filling the Eckardt Score, GERD-HRQL and RSI questionnaire and signing the informed consent form

I have achalasia and haven't been treated or my previous treatments didn't work.

Exclusion Criteria

I have damage to the lining of my lower esophagus, like ulcers or scars.

My BMI is 30 or higher.

I have serious heart or lung conditions that make anesthesia risky for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either POEM-F or conventional POEM procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of GERD and other outcomes

1 year

Multiple visits (in-person and virtual) at 1 month, 3 months, 6 months, and 1 year

Long-term Follow-up

Extended monitoring of GERD and other outcomes beyond the primary follow-up period

Additional 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional POEM
• POEM-F

Trial Overview The trial compares two procedures for achalasia: conventional POEM and a new method called POEM-F which includes an endoscopic fundoplication to potentially reduce gastroesophageal reflux disease (GERD) after the procedure. It's an international study measuring GERD incidence one year post-treatment.

How Is the Trial Designed?

Group I: Per-oral endoscopic myotomy with fundoplication Experimental Treatment 1 Intervention

The detail of the procedure has been reported in the literature. After completion of myotomy as per conventional anterior POEM, a serosal incision would be made at the level of the GE junction below the diaphragmatic crus. The peritoneal cavity would then be entered and the anterior gastric wall could be identified. A detachable endoloop would be introduced alongside the endoscope with the guidance of endoscopic clip. Three to four clips would be applied to the anterior gastric fundus while additional 3-4 clips would be applied to the edge of the submucosal tunnel, all anchoring to the endoloop. Upon tightening of the endoloop the anterior fundus would be approximated to the esophagogastric junction and thus completing the partial anterior fundoplication. Abdominal paracentesis to treat capnoperitoneum would be performed as required based on patient's clinical condition.

Group II: Conventional POEM Active Control 1 Intervention

Conventional per-oral endoscopic myotomy An anterior POEM would be performed per usual manner described in the literature. The procedure would be performed under general anaesthesia by expert endoscopists with at least 50 case experience of conventional POEM and 5 cases experience of POEM-F. The requirement of POEM experience is based on a recent multicenter study of learning curve by Fujiyoshi Y, et al. The procedure would follow the current recommendations from expert panel in reducing GER, including avoidance of excessive gastric myotomy and preservation of the sling fibers are the gastric cardia. The length of the esophageal and gastric myotomy is standardized at 5cm and 2cm respectively

Conventional POEM is already approved in European Union, United States, India, China for the following indications:

Approved in European Union as POEM for:

• Esophageal achalasia

Approved in United States as POEM for:

• Esophageal achalasia

Approved in India as POEM for:

• Esophageal achalasia

Approved in China as POEM for:

• Esophageal achalasia

Who Is Running the Clinical Trial?

Chinese University of Hong Kong

Lead Sponsor

Trials

1,387

Recruited

1,372,000+

Deenanath Mangeshkar Hospital and Research Centre

Collaborator

Trials

1

Recruited

80+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Northwestern University Feinberg School of Medicine

Collaborator

Trials

42

Recruited

15,500+

Asian Institute of Gastroenterology, India

Collaborator

Trials

99

Recruited

63,500+

Post Graduate Institute of Medical Education and Research, Chandigarh

Collaborator

Trials

311

Recruited

118,000+

Nanfang Hospital, Southern Medical University

Collaborator

Trials

571

Recruited

4,591,000+

Post Graduate Institute of Medical Education and Research, Chandigarh

Collaborator

Trials

2

Recruited

180+

Published Research Related to This Trial

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]

Per-oral endoscopic myotomy (POEM) is a minimally invasive and effective treatment for achalasia, with clinical remission rates ranging from 82% to 100%, and it shows similar outcomes to laparoscopic Heller myotomy in terms of perioperative and short- to long-term results.

The procedure is generally safe, with no reported deaths and a complication rate comparable to traditional surgery, but it requires specialized training due to its technical complexity and potential risks such as bleeding and perforation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Per-oral endoscopic myotomy (POEM): a new endoscopic treatment for achalasia. Miranda García, P., Casals Seoane, F., Gonzalez, JM., et al.[2018]

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]

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 33 patients undergoing peroral endoscopic myotomy (POEM) for esophageal motility disorders, 92% of achalasia patients and 75% of non-achalasia patients experienced significant improvement in dysphagia, demonstrating the efficacy of POEM in treating these conditions.

The procedure was found to be safe, with no mortality and a low complication rate (5.7%), while also allowing for flexible adjustments in the myotomy length and location, making it a versatile option for various esophageal motility issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A utility of peroral endoscopic myotomy (POEM) across the spectrum of esophageal motility disorders. Hoppo, T., Thakkar, SJ., Schumacher, LY., et al.[2022]

Per-oral endoscopic myotomy (POEM) demonstrated a high treatment success rate of over 90% at 12 months, although this decreased to 84% at 24 months, indicating it is an effective long-term treatment for achalasia.

However, more than one-third of patients experienced mild reflux symptoms or esophagitis post-procedure, highlighting the need for monitoring and potential management of reflux after POEM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Per-oral endoscopic myotomy (POEM): mid-term efficacy and safety. Martinek, J., Svecova, H., Vackova, Z., et al.[2019]

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]

The study of six patients undergoing peroral endoscopic myotomy with fundoplication (POEM-F) for achalasia showed that the procedure was technically successful in all cases, indicating its feasibility.

No major adverse events occurred within 30 days post-procedure, and significant improvements in symptoms were observed, with a marked reduction in the Eckardt score, suggesting effective treatment with a low risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical details and outcomes of peroral endoscopic myotomy with fundoplication: the first U.S. experience (with video). Shrigiriwar, A., Zhang, LY., Ghandour, B., et al.[2023]

Peroral endoscopic myotomy (POEM) is a safe and effective treatment for esophageal achalasia in children, as demonstrated by a study involving three children with an average age of 9.6 years, where no postoperative complications occurred.

After undergoing POEM, the two patients who were followed for 12 months experienced complete relief of symptoms and a significant reduction in lower esophageal sphincter pressure, indicating the procedure's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peroral endoscopic myotomy for the treatment of achalasia in children. Familiari, P., Marchese, M., Gigante, G., et al.[2022]

The peroral endoscopic myotomy with fundoplication (POEM-F) procedure was technically feasible in a study of 20 patients, achieving an 85% technical success rate and a median procedure time of 118 minutes.

While POEM-F showed reasonable short-term outcomes, including 58.8% of patients off proton pump inhibitors, concerns about the durability of the fundoplication and complications like fundal wrap loosening and ulceration highlight the need for further long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early outcomes of peroral endoscopic myotomy with fundoplication for achalasia cardia - Is it here to stay? Patil, G., Dalal, A., Maydeo, A.[2021]

The study involved 21 patients undergoing a new procedure called POEM+F, which combines peroral endoscopic myotomy with endoscopic fundoplication to address gastroesophageal reflux (GER) after standard POEM treatment.

POEM+F was successfully performed in all cases without any immediate or delayed complications, suggesting it is a safe and effective minimally invasive option for treating achalasia while potentially reducing the risk of GER.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peroral endoscopic myotomy and fundoplication: a novel NOTES procedure. Inoue, H., Ueno, A., Shimamura, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4873884/

Efficacy of peroral endoscopic myotomy vs other achalasia ... CONCLUSION: POEM, PD and LHM were all effective in improving esophageal function in achalasia at short-term. There was no difference in efficacy between the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4699718/

Peroral Endoscopic Myotomy for Treating Achalasia and ... Accumulating data about POEM demonstrate excellent short-term outcomes with minimal risk of major adverse events, and some existing long-term data show the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X23008971

the Past, Present and Future of Per-Oral Endoscopic ... Multiple favorable long-term studies have been published advocating for the use of POEM as a valid and perhaps the most valid treatment option for achalasia.

4. ales.amegroups.org ales.amegroups.org/article/view/10072/html

Peroral endoscopic myotomy (POEM) for the treatment of ... Conclusions: POEM appears to be a safe and effective endoscopic treatment, alternative to laparoscopic Heller myotomy in the treatment of achalasia. However, ...

5. 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 ...

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

Long-term outcomes of per-oral endoscopic myotomy in ... Conclusion POEM is a durable and safe procedure with an acceptably low adverse event rate and an excellent long-term clinical response. Introduction. Per-oral ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4533050/

Peroral endoscopic myotomy for achalasia in patients aged ... The study results suggest that POEM is safe and effective in elderly patients with achalasia. It is a less-invasive endoscopic procedure, and shows good results ...

8. cardiothoracicsurgery.biomedcentral.com cardiothoracicsurgery.biomedcentral.com/articles/10.1186/s13019-018-0811-9

The 2 years' long-term efficacy and safety of peroral ... Conclusions. Our study demonstrated that POEM is effective and safe for treating achalasia during the long-term followed up over 2 years.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X23040696

Peroral Endoscopic Myotomy (POEM) Is Safe and Effective ... Conclusion. POEM is safe and effective even following preoperative endoscopic large caliber balloon dilations or botox injection. These interventions do not ...