G-POEM for Gastroparesis

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

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new procedure called G-POEM in patients whose gastroparesis doesn't get better with medication. The goal is to see if G-POEM helps these patients by making it easier for food to leave the stomach. G-POEM is a novel endoscopic technique developed to treat refractory gastroparesis, especially in patients who have not responded to other treatments like gastric electrical stimulators.

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.

What data supports the idea that G-POEM for Gastroparesis is an effective treatment?

The available research shows that G-POEM is a promising treatment for gastroparesis. Studies have found that it is a minimally invasive technique that can be effective for patients who do not respond to other treatments. One study compared G-POEM to surgical pyloroplasty, a more traditional surgery, and found that G-POEM had positive clinical outcomes. This suggests that G-POEM could be a good alternative to more invasive surgeries for treating gastroparesis. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment G-POEM for gastroparesis?

Research shows that G-POEM, a minimally invasive procedure, is promising for treating gastroparesis, especially when other treatments haven't worked. Studies suggest it can improve symptoms by helping the stomach empty more effectively. ^{1 2 3 4 5}

What safety data is available for G-POEM treatment?

The safety of G-POEM has been studied in various research articles. A comprehensive international multicenter study analyzed adverse events associated with G-POEM, indicating a focus on understanding its safety profile. Additionally, a systematic review and meta-analysis compared G-POEM with surgical pyloroplasty, providing insights into its safety and efficacy. These studies suggest that while G-POEM is a promising treatment for gastroparesis, it is still considered experimental, and safety data is being actively evaluated. ^{2 4 5 6 7}

Is G-POEM safe for humans?

G-POEM (Gastric Peroral Endoscopic Myotomy) is generally considered safe, but like any medical procedure, it can have some risks. A study analyzing adverse events (unwanted side effects) found that while G-POEM is effective, it is important to understand the potential risks involved. ^{2 4 5 6 7}

Is G-POEM a promising treatment for gastroparesis?

Yes, G-POEM is a promising treatment for gastroparesis. It is a new, minimally invasive technique that has shown potential in improving symptoms for patients with this condition. ^{1 2 4 5 8}

How is the G-POEM treatment different from other treatments for gastroparesis?

G-POEM is a novel, minimally invasive endoscopic procedure that involves cutting the muscle at the pylorus (the opening from the stomach to the small intestine) to improve stomach emptying, unlike traditional surgical methods. ^{1 2 4 5 8}

Research Team

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

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

G-POEM with antro-pyloromyotomy for the treatment of refractory gastroparesis: mid-term follow-up and factors predicting outcome. [2018]

2. Germany 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. [2021]

3. Spain 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. [2021]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

Successful repeated gastric peroral endoscopic myotomy (re-G-POEM) in the treatment of postsurgical gastroparesis. [2022]

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

Gastric Peroral Endoscopic Myotomy: A Specific Learning Curve. [2023]

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

Comprehensive Analysis of Adverse Events Associated with Gastric Peroral Endoscopic Myotomy: An International Multicenter Study. [2021]

7. Czech Republic 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. [2020]

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

Gastric Per Oral Endoscopic Myotomy (G-POEM) for the Treatment of Refractory Gastroparesis: Early Experience. [2018]