G-POEM for Gastroparesis

No longer recruiting at 1 trial location

Overseen By Pankaj Pasricha, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Prokinetics, GLP-1 analogs, Narcotics

Disqualifiers: Chronic renal failure, Liver disease, Diabetes, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a procedure called G-POEM (Gastric Peroral Endoscopic Myotomy) can help individuals with gastroparesis, a condition where the stomach doesn't empty food properly, causing nausea and vomiting. It compares G-POEM to a sham surgery to determine which is more effective over a year. Individuals with chronic nausea or vomiting for at least a year, whose gastroparesis hasn't improved with medication, may be suitable candidates. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance future treatment options.

Do I have to stop taking my current medications for the trial?

You must stop using prokinetic agents, GLP-1 analogs or agonists, and drugs that slow gastric emptying. Neuromodulators like tricyclic antidepressants can continue if used at stable doses for a month before the trial, at your care provider's discretion.

Will I have to stop taking my current medications?

The trial requires that you stop using prokinetic agents, GLP-1 analogs or agonists, and drugs that slow down gastric emptying. However, if you are using neuromodulators like tricyclic antidepressants at stable doses, you may continue them with your care provider's approval.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that G-POEM, the treatment under study, is safe for people with gastroparesis. Several studies have found that G-POEM can provide long-lasting symptom relief and is generally well-tolerated by most patients. In one study, researchers observed 102 patients for four years, and 77.5% experienced symptom improvement. Another study noted that while the treatment is effective, there is a 13% annual chance of symptom recurrence. Overall, G-POEM is considered a safe procedure with positive results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

G-POEM is unique because it offers a minimally invasive approach to treating gastroparesis by performing a gastric peroral endoscopic myotomy. Unlike the standard treatments, which often involve medications to stimulate stomach muscles or surgery to implant devices, G-POEM targets the pylorus directly to improve gastric emptying. Researchers are excited about this technique because it has the potential to provide relief more effectively and with fewer complications, offering a promising alternative for patients who do not respond well to current options.

What evidence suggests that G-POEM is effective for gastroparesis?

Research has shown that G-POEM, one of the treatments studied in this trial, effectively treats gastroparesis, a condition where the stomach struggles to empty. One study found that 85.1% of patients improved based on a test measuring stomach emptying speed. Another study reported a 77.5% success rate after four years. G-POEM has been particularly beneficial for individuals whose gastroparesis results from diabetes, past surgeries, or unknown causes. It even aids those who did not improve with other treatments. Overall, G-POEM appears promising in relieving symptoms for many with this condition. Participants in this trial may receive either G-POEM or a Sham procedure as part of the study. ^{3 5 6 7 8}

Who Is on the Research Team?

Michael Camilleri, M.D., D.Sc.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with gastroparesis, a condition causing chronic nausea or vomiting, who haven't improved after trying standard treatments for at least six months. Participants must have confirmed delayed gastric emptying and a specific symptom severity score. Excluded are those with other conditions that could explain symptoms, severe systemic illnesses, uncontrolled diabetes, recent changes in medications for gastroparesis, pregnancy, or certain allergies.

Inclusion Criteria

My stomach empties slowly, with tests showing more than 25% of food remains after 4 hours.

My severe stomach emptying issue hasn't improved despite trying many treatments.

I have had symptoms like chronic nausea or vomiting for at least a year.

Exclusion Criteria

I am currently taking medication that affects stomach emptying or mood stabilizers.

Failure to give informed consent.

You are allergic to eggs or egg-based products like Egg Beaters and Ensure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo G-POEM or sham surgery to evaluate the treatment effect on gastroparesis

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• G-POEM
• Sham G-POEM

Trial Overview The study compares the effectiveness of G-POEM (a surgical procedure to cut stomach muscles) against sham surgery (a fake operation) over 12 months in patients whose gastroparesis doesn't respond to medication. The goal is to see which treatment helps more and identify factors predicting better outcomes.

How Is the Trial Designed?

Group I: G-POEM Experimental Treatment 1 Intervention

Group II: Sham procedure Placebo Group 1 Intervention

G-POEM is already approved in United States, European Union for the following indications:

Approved in United States as G-POEM for:

• Gastroparesis

Approved in European Union as G-POEM for:

• Gastroparesis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A 31-year-old female patient with severe refractory gastroparesis underwent a second gastric peroral endoscopic myotomy (G-POEM) after the first procedure failed to improve her condition, demonstrating the feasibility of repeated G-POEM in such cases.

The second G-POEM led to significant clinical improvement and better gastric emptying, suggesting that repeated procedures may be beneficial for patients with persistent pylorospasm, although the reasons for the initial failure remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful repeated gastric peroral endoscopic myotomy (re-G-POEM) in the treatment of postsurgical gastroparesis. Dražilová, D., Vacková, Z., Husťak, R., et al.[2022]

Gastric per oral endoscopic myotomy (G-POEM) is a safe and feasible procedure for treating refractory gastroparesis, with no reported procedure-related side effects in a study of 13 patients with various underlying causes.

Most patients (8 out of 11) reported subjective improvement in symptoms after G-POEM, particularly in vomiting, retching, and loss of appetite, indicating potential efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric Per Oral Endoscopic Myotomy (G-POEM) for the Treatment of Refractory Gastroparesis: Early Experience. Malik, Z., Kataria, R., Modayil, R., et al.[2018]

Gastric peroral endoscopic myotomy (G-POEM) shows a clinical success rate of 75.8% for treating refractory gastroparesis, which is comparable to the 77.3% success rate of surgical pyloroplasty, based on the Gastroparesis Cardinal Symptom Index (GCSI) score.

The study found that factors like idiopathic gastroparesis and previous treatments with botulinum toxin or gastric stimulators may positively predict the success of G-POEM, indicating its potential effectiveness in specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of gastric per-oral endoscopic myotomy (G-POEM) in the treatment of refractory gastroparesis and predictors of outcomes: a systematic review and meta-analysis using surgical pyloroplasty as a comparator group. Mohan, BP., Chandan, S., Jha, LK., et al.[2021]

In a study of 9 patients with severe refractory gastroparesis, G-POEM (endoscopic pyloromyotomy) was effective in 88.9% of cases, showing significant improvement in symptoms and gastric emptying over a median follow-up of 23 months.

The procedure was safe, with only one case of delayed bleeding that was successfully treated, and all other patients recovered without complications, indicating that G-POEM is a promising long-term treatment option for refractory gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Per-oral endoscopic pyloromyotomy (g-poem) for the treatment of gastroparesis - a pilot single-centre study with mid-term follow-up. Husťak, R., Vacková, Z., Krajciova, J., et al.[2020]

Gastric peroral endoscopic myotomy (G-POEM) is a safe procedure for treating refractory gastroparesis, with 14% of patients experiencing adverse events (AEs), mostly mild and manageable.

The likelihood of experiencing AEs is significantly lower for endoscopists who have performed more than 20 G-POEM procedures, highlighting the importance of experience in reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Analysis of Adverse Events Associated with Gastric Peroral Endoscopic Myotomy: An International Multicenter Study. Ichkhanian, Y., Vosoughi, K., Aghaie Meybodi, M., et al.[2021]

Gastric peroral endoscopic pyloromyotomy (G-POEM) demonstrated a mid-term clinical success rate of 69% at 6 months for treating refractory gastroparesis, with significant improvements in symptoms as measured by the Gastroparesis Cardinal Symptoms Index (GCSI).

The procedure was technically successful in all 29 patients, with a low complication rate (only two minor complications), indicating that G-POEM is a safe and reproducible treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

G-POEM with antro-pyloromyotomy for the treatment of refractory gastroparesis: mid-term follow-up and factors predicting outcome. Gonzalez, JM., Benezech, A., Vitton, V., et al.[2018]

Gastric per-oral endoscopic myotomy (G-POEM) demonstrated a 100% technical success rate in treating refractory gastroparesis among 235 patients, significantly improving symptoms as measured by the Gastroparesis Cardinal Symptom Index (GCSI) and gastric emptying times.

The procedure had a relatively low complication rate of 5.1% during the procedure and 6.8% post-procedure, with complications being manageable, indicating that G-POEM is a safe option for patients with refractory gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric per-oral endoscopic myotomy (G-POEM) is a promising treatment for refractory gastroparesis: a systematic review and meta-analysis. Yan, J., Tan, Y., Zhou, B., et al.[2021]

Gastric peroral endoscopic pyloromyotomy (G-POEM) is a promising treatment for gastroparesis, showing a significant reduction in symptoms and gastric emptying times in a study of 36 patients over 15 months.

The study found that the procedure time decreased significantly with experience, reaching an average of 60.5 minutes by the 18th case, indicating a learning curve that improves efficiency for endoscopists performing G-POEM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric Peroral Endoscopic Myotomy: A Specific Learning Curve. Reja, M., Mishra, A., Tyberg, A., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31583465/

Clinical efficacy of gastric per-oral endoscopic myotomy (G ... The pooled rate of clinical success, based on the 4-hour GES results, with G-POEM was 85.1% (95% CI 68.9-93.7, I2 = 74) and with surgical ...

2. igiejournal.org igiejournal.org/article/S2949-7086(23)00082-1/fulltext

Long-term outcomes (≥3 years) after gastric peroral ... The primary outcome was clinical success 3 years after G-POEM. Secondary outcomes included changes in Gastroparesis Cardinal Symptom Index score ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(23)00212-3/fulltext

AGA Clinical Practice Update on Gastric Peroral ... One hundred and two patients completed 48 months of follow-up and the clinical success rate at 4 years was 77.5%. Patients with diabetic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S221074012400202X

Efficacy of gastric per-oral endoscopic myotomy remains ... G-POEM is safe and remains effective after GES or previous pyloric treatment failure, with 50% efficacy at 6 months. The therapeutic strategy in refractory ...

5. gastro.org gastro.org/clinical-guidance/update-on-gastric-peroral-endoscopic-myotomy-g-poem-for-gastroparesis/

Update on gastric peroral endoscopic myotomy (G-POEM ... G-POEM has been found to be efficacious in treating patients with gastroparesis from diabetes, prior surgery and idiopathic causes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10052481/

Gastric peroral endoscopic pyloromyotomy (G-POEM) in ... Three studies showed that at the 4-year follow-up, the response to G-POEM was durable, but there was a yearly recurrence rate of 13% or more.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000296102500025X

Long term outcomes of gastric per oral endoscopic ... G-POEM is a safe procedure that shows promising long-term outcomes for gastroparesis symptom relief. Larger studies with more complete follow-up are needed.

8. giejournal.org giejournal.org/article/S0016-5107(24)03461-8/abstract

Efficacy and safety of gastric peroral endoscopic myotomy ... Based on this meta-analysis, G-POEM is effective and safe for treating refractory gastroparesis irrespective of the etiology, with significant ...