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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory 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 data supports the effectiveness of the treatment Endoscopic Pyloromyotomy for Gastroparesis?

Research shows that Gastric Peroral Endoscopic Myotomy (G-POEM), a type of endoscopic pyloromyotomy, is a promising and effective procedure for treating gastroparesis, especially when other treatments have failed. Studies indicate that it can improve symptoms in patients with gastroparesis, although more research is needed to standardize techniques and improve outcomes. ^{1 2 3 4 5}

Is endoscopic pyloromyotomy generally safe for humans?

Endoscopic pyloromyotomy, also known as G-POEM or POP, is considered a promising and feasible procedure for treating gastroparesis, with studies focusing on its safety and feasibility. While more research is needed to standardize techniques and improve outcomes, it is emerging as a safe option, especially for those who have not responded to other treatments. ^{1 2 3 4 6}

How is the treatment Endoscopic Per-oral Pyloromyotomy (POP) unique for gastroparesis?

Endoscopic Per-oral Pyloromyotomy (POP) is a novel treatment for gastroparesis that involves cutting the pyloric muscle using an endoscopic technique, which is less invasive than traditional surgical methods. This approach is unique because it allows for a minimally invasive procedure that can be performed endoscopically, potentially reducing recovery time and complications compared to laparoscopic surgery. ^{1 2 3 4 6}

Research Team

Matthew Allemang, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

I have completed evaluations by specialists for my gastroparesis.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

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

Technical Aspects of Peroral Endoscopic Pyloromyotomy. [2019]

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

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

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

Safety and Feasibility of Per-Oral Pyloromyotomy as Augmentative Therapy after Prior Gastric Electrical Stimulation for Gastroparesis. [2020]

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

Outcomes of per oral endoscopic pyloromyotomy in gastroparesis worldwide. [2020]

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

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

6. United States 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. [2021]