Endoscopic Pyloromyotomy for Gastroparesis

(EMPTIES Trial)

Overseen By Karim Kheniser

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Allemang

Must not be taking: Narcotics, Anticoagulants

Disqualifiers: Pregnancy, Egg allergy, Post-surgical gastroparesis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for gastroparesis, a condition where the stomach can't empty food properly, causing symptoms like nausea and bloating. The study tests a procedure called endoscopic per-oral pyloromyotomy (POP), which may improve stomach function, against a control procedure that doesn't alter the stomach. Individuals who have experienced gastroparesis for over six months without relief from other treatments might be suitable candidates. Participants will receive either the POP treatment or a sham procedure, with an option for the treatment later if symptoms persist. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to new treatment options for gastroparesis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively using narcotic pain medication or anticoagulant medications (except antiplatelet therapy).

What prior data suggests that endoscopic per-oral pyloromyotomy (POP) is safe for treating gastroparesis?

Research has shown that endoscopic per-oral pyloromyotomy (POP) is generally safe for people with gastroparesis. Studies indicate that this treatment reduces symptoms like stomach pain in more than half of the patients. While many patients experience relief, some may not notice as much improvement, so results can vary.

Most patients handle POP well, and there have been no widespread reports of serious side effects. However, like any procedure, some risk exists. It's important to discuss any concerns with a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endoscopic per-oral pyloromyotomy (POP) for gastroparesis because it offers a unique approach compared to current treatments like dietary changes, medications, or gastric electrical stimulation. Unlike these standard methods, POP directly targets and loosens the pylorus muscle through a minimally invasive endoscopic technique, potentially improving stomach emptying. This method could lead to faster symptom relief and fewer side effects since it doesn't involve external devices or long-term medication use. Additionally, for patients who don't respond to traditional management, POP could provide a new and effective option.

What evidence suggests that endoscopic per-oral pyloromyotomy (POP) might be an effective treatment for gastroparesis?

Research has shown that endoscopic per-oral pyloromyotomy (POP), which participants in this trial may receive, effectively treats gastroparesis, a condition where the stomach struggles to empty. In studies, 56% to 73% of patients reported reduced stomach pain after the procedure. Long-term research indicates that POP is highly successful, with 98.6% of patients experiencing both technical and clinical improvements. After four years, 77.5% of patients continued to benefit from the treatment. This suggests that POP could be a promising option for those whose symptoms don't improve with other treatments. Meanwhile, participants in the control arm will undergo a diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption. ^{1 2 4 6 7}

Who Is on the Research Team?

Matthew Allemang, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with severe gastroparesis not improved by at least 6 months of medical treatment. Participants must be able to travel for assessments, take oral meds, follow dietary/medication regimens post-procedure, and use effective contraception if applicable. Excluded are those with post-surgical gastroparesis, pregnant or breastfeeding individuals, uncontrolled blood clotting issues, egg allergies, prior stomach surgeries or on parenteral nutrition.

Inclusion Criteria

Ability to take oral medication and be willing to adhere to the post-procedure dietary and medication regimen

I have completed evaluations by specialists for my gastroparesis.

For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Exclusion Criteria

I am receiving nutrition through an IV.

You are currently taking strong pain medication.

You have had an allergic reaction to eggs in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either endoscopic per-oral pyloromyotomy (POP) or a sham diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption

12 weeks

1 visit (in-person) for procedure

Follow-up

Participants are monitored for changes in symptoms and gastric emptying

12 weeks

Regular follow-up visits (frequency not specified)

Open-label extension (optional)

Participants in the sham group may opt into endoscopic per-oral pyloromyotomy (POP) if they remain symptomatic

What Are the Treatments Tested in This Trial?

Interventions

• Diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption
• Endoscopic per-oral pyloromyotomy (POP)

Trial Overview The study compares an endoscopic procedure called per-oral pyloromyotomy (POP), which cuts the muscle at the stomach exit to improve emptying against a sham intervention without this cut in patients with tough-to-treat gastroparesis.

How Is the Trial Designed?

Group I: Endoscopic per-oral pyloromyotomy (POP) Active Control 1 Intervention

Participants will undergo Endoscopic per-oral pyloromyotomy (POP).

Group II: Sham / Control Arm Placebo Group 2 Interventions

Participants will undergo a diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption. Following the 12-week blinded trial period, these participants will be unblinded and offered Endoscopic per-oral pyloromyotomy (POP) if they remain symptomatic.

Endoscopic per-oral pyloromyotomy (POP) is already approved in United States, European Union, Japan for the following indications:

Approved in United States as G-POEM/POP for:

• Medically refractory gastroparesis

Approved in European Union as G-POEM/POP for:

• Medically refractory gastroparesis

Approved in Japan as G-POEM/POP for:

• Medically refractory gastroparesis

Who Is Running the Clinical Trial?

Matthew Allemang

Lead Sponsor

Trials

2

Recruited

140+

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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 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]

In a study of 11 patients undergoing per-oral endoscopic pyloromyotomy (POP) for gastroparesis, 86% showed normal gastric emptying three months post-surgery, indicating effective treatment.

POP demonstrated significantly lower complication rates and shorter hospital stays compared to the laparoscopic equivalent, with no complications observed in the POP group versus a predicted 10.05% for laparoscopic pyloromyotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Per-oral Pyloromyotomy for Gastroparesis: Initial Experience and Postoperative Comparison to Predicted Complications Following Laparoscopic Pyloromyotomy as Calculated by the ACS Risk Calculator. Ward, MA., Hasan, SS., Whitfield, EP., et al.[2021]

Per oral endoscopic pyloromyotomy (POP) shows promise as a treatment for gastroparesis, but its safety and efficacy require thorough evaluation as more data becomes available.

Further research is needed to identify which patients are most likely to benefit from GPOEM, as understanding predictive factors for clinical success is crucial for optimizing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of per oral endoscopic pyloromyotomy in gastroparesis worldwide. Mekaroonkamol, P., Shah, R., Cai, Q.[2020]

Gastric peroral endoscopic pyloromyotomy (G-POEM) is an effective treatment for refractory gastroparesis, demonstrating feasibility in clinical practice.

The procedure involves several key technical steps, but there is currently no standardized technique, indicating a need for further research to optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Aspects of Peroral Endoscopic Pyloromyotomy. Tao, J., Patel, V., Mekaroonkamol, P., et al.[2019]

Per-oral pyloromyotomy (POP) is a safe and feasible treatment for patients experiencing recurrent symptoms of gastroparesis after gastric electrical stimulation (GES), with no complications reported in the study of 22 patients.

Patients showed significant improvement in symptoms, as measured by the Gastroparesis Cardinal Symptom Index, with an average reduction of 1.63 points, and 7 out of 11 patients had normal gastric motility or emptying studies post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Per-Oral Pyloromyotomy as Augmentative Therapy after Prior Gastric Electrical Stimulation for Gastroparesis. Strong, AT., Rodriguez, J., Kroh, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6397720/

Outcomes of per oral endoscopic pyloromyotomy in ... Improvement in abdominal pain has been reported in 56%-73% of patients after POP but the follow-up period in these studies were only up to 11.5 ...

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, defined by improvement in symptoms and a decrease in GSCI score. Secondary outcomes included changes ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949708623000821

Long-term outcomes (≥3 years) after gastric peroral ... We found that G-POEM is an effective long-term treatment option for patients with refractory gastroparesis, with technical and clinical success rates of 98.6% ...

4. 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 ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8790331/

Gastric per-oral endoscopic myotomy: Indications ... Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy ...

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.